127. 前頭側頭葉変性症 Frontotemporal lobar degeneration Clinical trials / Disease details


臨床試験数 : 89 薬物数 : 104 - (DrugBank : 33) / 標的遺伝子数 : 40 - 標的パスウェイ数 : 117

  
No.TrialIDDate_
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PhaseCountries
1NCT05262023
(ClinicalTrials.gov)
February 1, 20221/2/2022A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)A Phase 1/2, Multicenter, Randomized, Placebo-Controlled, Double Blind Single Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia Followed by an Open-Label ExtensionFrontotemporal DementiaDrug: DNL593;Drug: PlaceboDenali Therapeutics Inc.TakedaRecruiting18 Years80 YearsAll106Phase 1/Phase 2United Kingdom
2EUCTR2021-002251-11-ES
(EUCTR)
31/01/202208/10/2021A clinical study to learn whether a new drug, TPN-101, is safe when given to patients with amyotrophic lateral sclerosis or frontotemporal dementia due to a genetic mutation called C9orf72 hexanucleotide repeat expansion.A Phase 2a Study of TPN-101 in Patients with C9ORF72 ALS/FTD (Amyotrophic Lateral Sclerosis and/or Frontotemporal Dementia) Amyotrophic lateral sclerosis or frontotemporal dementia due to a genetic mutation called C9orf72 hexanucleotide repeat expansion
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: TPN-101
Product Code: TPN-101
INN or Proposed INN: CENSAVUDINE
Transposon Therapeutics, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France;United States;Canada;Belgium;Spain;Netherlands;Germany;United Kingdom
3EUCTR2020-005193-94-SE
(EUCTR)
26/01/202212/10/2021Phase 1b/2a Study of WVE-004 in Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD)A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-004 Administered Intrathecally to Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: WVE-004
INN or Proposed INN: not yet assigned
Other descriptive name: Synthetic stereopure antisense oligonucleotide targeting human C9orf72 hexanucleotide repeat-containing mRNA transcripts
Wave Life Sciences UK LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 1;Phase 2United States;Canada;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom;New Zealand;Sweden
4EUCTR2020-005193-94-BE
(EUCTR)
26/01/202215/10/2021Phase 1b/2a Study of WVE-004 in Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD)A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-004 Administered Intrathecally to Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: WVE-004
INN or Proposed INN: not yet assigned
Other descriptive name: Synthetic stereopure antisense oligonucleotide targeting human C9orf72 hexanucleotide repeat-containing mRNA transcripts
Wave Life Sciences UK LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 1;Phase 2United States;Canada;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom;New Zealand;Sweden
5NCT05184569
(ClinicalTrials.gov)
January 20, 202217/12/2021Veri-T: A Trial of Verdiperstat in Patients With svPPA Due to TDP-43 PathologyPhase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of Oral Verdiperstat (BHV-3241) in Patients With Semantic Variant Primary Progressive Aphasia (svPPA) Due to TDP-43 PathologySemantic DementiaDrug: VerdiperstatPeter Ljubenkov, MDNational Institutes of Health (NIH);Alzheimer's Association;National Institute on Aging (NIA)Not yet recruiting18 Years85 YearsAll64Phase 1NULL
6NCT05288842
(ClinicalTrials.gov)
December 1, 202127/7/2021Tanycytes in Alzheimer's Disease and Frontotemporal DementiaTANYCYTES' ROLE IN ALZHEIMER'S DISEASE AND FRONTOTEMPORAL DEMENTIA: ARE THEY THE KEY TO WELL AGING?Alzheimer Disease;Frontotemporal DementiaBiological: Lumbar puncture;Biological: blood sampleUniversity Hospital, LilleEuropean Research CouncilRecruiting40 Years85 YearsAll102France
7NCT04993755
(ClinicalTrials.gov)
October 1, 202119/7/2021A Phase 2a Study of TPN-101 in Patients With C9ORF72 ALS/FTDA Phase 2a Study of TPN-101 in Patients With Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD) Associated With Hexanucleotide Repeat Expansion in the C9orf72 Gene (C9ORF72 ALS/FTD)Amyotrophic Lateral Sclerosis;Frontotemporal DementiaDrug: TPN-101, 400 mg/day;Drug: PlaceboTransposon Therapeutics, Inc.NULLRecruiting18 YearsN/AAll40Phase 2United States;France
8NCT04747431
(ClinicalTrials.gov)
September 14, 20212/2/2021A Study of PBFT02 in Patients With Frontotemporal Dementia and Progranulin Mutations (FTD-GRN)A Phase 1b Open-Label, Multicenter, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacodynamic Effects of a Single Dose of PBFT02 Delivered Into the Cisterna Magna of Adult Subjects With Frontotemporal Dementia and Mutations in the Progranulin GeneFrontotemporal DementiaDrug: PBFT02Passage Bio, Inc.NULLRecruiting35 Years75 YearsAll6Phase 1/Phase 2United States;Brazil;Canada;Italy;Portugal;United Kingdom
9NCT04931862
(ClinicalTrials.gov)
June 28, 202111/6/2021Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD)A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-004 Administered Intrathecally to Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD)ALS;FTDDrug: WVE-004;Drug: PlaceboWave Life Sciences Ltd.NULLRecruiting18 Years80 YearsAll42Phase 1/Phase 2Australia;Canada;Ireland;Netherlands;United Kingdom
10NCT04937452
(ClinicalTrials.gov)
June 3, 202116/6/2021Dopaminergic Therapy for Frontotemporal Dementia PatientsDopaminergic Therapy for Frontotemporal Dementia Patients: an Interventional, Multi-site, Randomized, Double-blind, Placebo-controlled Study on the Efficacy and Safety of RTG Treatment in Patients With Behavioral FTDFrontotemporal Dementia;Dementia;Aphasia, Primary Progressive;Pick Disease of the Brain;Brain Diseases;Central Nervous System Diseases;Nervous System Diseases;Neurocognitive Disorders;Mental Disorders;Neurodegenerative Diseases;Frontotemporal Lobar Degeneration;TDP-43 Proteinopathies;Proteostasis Deficiencies;Metabolic Disease;Aphasia;Speech Disorders;Language Disorders;Communication Disorders;Neurobehavioral Manifestations;Neurologic ManifestationsDrug: Rotigotine 4Mg/24Hrs Patch;Drug: Rotigotine 6Mg/24Hrs Patch;Drug: PlaceboI.R.C.C.S. Fondazione Santa LuciaAlzheimer's Drug Discovery FoundationRecruiting40 Years80 YearsAll75Phase 2Italy
11EUCTR2019-004066-18-FR
(EUCTR)
04/02/202130/06/2020A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTDA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
12EUCTR2020-002672-12-NL
(EUCTR)
11/12/202008/10/2020Imaging of neuroinflammation in frontotemporal dementia by means of PET-MRIFrontotemporal dementia Imaging of Neuroinflammation, Degeneration and Microglia-Related Effects - FIND-MORE Frontotemporal dementia (FTD), including symptomatic patients and presymptomatic individuals with genetic mutations predisposing to FTD at a later stage in life.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: [18F]DPA-714
INN or Proposed INN: [18F]DPA-714
Other descriptive name: [18-F]DPA-714
Erasmus Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 2Netherlands
13EUCTR2019-004066-18-GB
(EUCTR)
03/12/202025/09/2020A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTDA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Portugal;United States;Spain;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
14NCT04408625
(ClinicalTrials.gov)
November 9, 202021/5/2020Phase 1/2 Clinical Trial of PR006 in Patients With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN)A Phase 1/2 Ascending Dose Study to Evaluate the Safety and Effects on Progranulin Levels of PR006A in Patients With Fronto-Temporal Dementia With Progranulin Mutations (FTD-GRN)Frontotemporal DementiaBiological: PR006;Drug: Methylprednisolone;Drug: Sirolimus;Drug: Prednisone;Drug: RituximabPrevail TherapeuticsEli Lilly and CompanyRecruiting30 Years80 YearsAll15Phase 1/Phase 2United States;Australia;Spain
15NCT04680130
(ClinicalTrials.gov)
November 1, 20203/11/2020Clinico-Pathologic-Genetic-Imaging Study of Neurodegenerative and Related DisordersClinico-Pathologic-Genetic-Imaging Study of Neurodegenerative and Related DisordersApraxia of Speech;PSP;CBD;PCA;LPA;Semantic Dementia;Semantic Aphasia;Behavioral Variant of Frontotemporal Dementia;FTD;PPADrug: C-11 PiB;Drug: AV1451 TauMayo ClinicNULLRecruiting21 YearsN/AAll500United States
16EUCTR2019-004066-18-SE
(EUCTR)
06/10/202010/06/2020A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTDA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk For or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
17EUCTR2019-004066-18-NL
(EUCTR)
02/09/202003/03/2020A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTDA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk For or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden
18EUCTR2019-004066-18-BE
(EUCTR)
31/07/202026/05/2020A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTDA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk For or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
19NCT04374136
(ClinicalTrials.gov)
July 23, 202023/4/2020A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin GeneFrontotemporal DementiaDrug: AL001;Drug: Placebo;Drug: Open label - AL001Alector Inc.NULLRecruiting25 Years85 YearsAll180Phase 3United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Portugal;Spain;Sweden;Switzerland;United Kingdom
20EUCTR2019-004066-18-DE
(EUCTR)
06/07/202020/02/2020A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTDA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk For or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Portugal;United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
21EUCTR2019-004066-18-PT
(EUCTR)
29/05/202021/02/2020A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTDA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Portugal;United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
22EUCTR2019-004066-18-IT
(EUCTR)
18/05/202015/06/2021A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTD.A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene. - NA Frontotemporal Dementia.
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: [AL001]
INN or Proposed INN: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Germany;Netherlands;Sweden;United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia
23EUCTR2019-004066-18-ES
(EUCTR)
22/04/202006/03/2020A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTDA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Portugal;France;Canada;Belgium;Spain;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
24NCT04220021
(ClinicalTrials.gov)
January 10, 20203/1/2020Safety and Therapeutic Potential of the FDA-approved Drug Metformin for C9orf72 ALS/FTDA Single-Center, Open Label Study to Assess the Safety and Tolerability of Metformin in Subjects With C9orf72 Amyotrophic Lateral Sclerosis Over 24 Weeks of TreatmentC9orf72 Amyotrophic Lateral Sclerosis (ALS);Frontotemporal DementiaDrug: MetforminUniversity of FloridaNULLRecruiting18 Years80 YearsAll18Phase 2United States
25EUCTR2019-000138-20-GB
(EUCTR)
18/11/201921/05/2019An Open-Label Study to Evaluate Safety of long-term AL001 dosing in FTDA Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9ORF72 Mutations Causative of Frontotemporal Dementia Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 2United States;Canada;Netherlands;Germany;Italy;United Kingdom
26EUCTR2019-000138-20-DE
(EUCTR)
08/10/201927/05/2019An Open-Label Study to Evaluate Safety of long-term AL001 dosing in FTDA Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9orf72 Mutations Causative of Frontotemporal Dementia Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: Latozinemab
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;Canada;Netherlands;Germany;United Kingdom;Italy
27NCT03987295
(ClinicalTrials.gov)
September 27, 201914/5/2019A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9orf72 Mutations Causative of Frontotemporal DementiaFrontotemporal DementiaDrug: AL001Alector Inc.NULLRecruiting18 Years85 YearsAll40Phase 2United States;Canada;Germany;Italy;Netherlands;United Kingdom
28EUCTR2019-000138-20-IT
(EUCTR)
24/09/201915/01/2021An Open-Label Study to Evaluate Safety of long-term AL001 dosing in FTDA Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9ORF72 Mutations Causative of Frontotemporal Dementia - - Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: [AL001]
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 2United States;Canada;Netherlands;Germany;United Kingdom;Italy
29EUCTR2019-000138-20-NL
(EUCTR)
20/09/201906/06/2019An Open-Label Study to Evaluate Safety of long-term AL001 dosing in FTDA Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9orf72 Mutations Causative of Frontotemporal Dementia Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;Canada;Germany;Netherlands;United Kingdom;Italy
30NCT04115384
(ClinicalTrials.gov)
September 9, 20192/10/2019Intranasal Insulin in Frontotemporal Dementia (FTD)A Single Center Feasibility Study of Intranasal Insulin in Frontotemporal Dementia NIFT-DFrontotemporal Dementia, Behavioral VariantDrug: Novolin-R insulinHealthPartners InstituteNULLSuspended41 Years89 YearsAll12Phase 2United States
31NCT04489017
(ClinicalTrials.gov)
June 1, 201913/4/2020Palmitoylethanolamide Combined With Luteoline in Frontotemporal Dementia Patients. A Randomized Controlled TrialPalmitoylethanolamide Combined With Luteoline in Frontotemporal Dementia Patients. A Randomized Controlled TrialFrontotemporal DementiaDietary Supplement: PEA-LUT;Dietary Supplement: PLACEBOI.R.C.C.S. Fondazione Santa LuciaNULLRecruiting40 Years80 YearsAll50N/AItaly
32NCT03636204
(ClinicalTrials.gov)
September 14, 201812/7/2018A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) MutationA First in Human Phase 1 Study in Healthy Volunteers and in Participants With Frontotemporal Dementia (FTD) With Granulin MutationHealthy;Frontotemporal DementiaBiological: AL001;Other: PlaceboAlector Inc.NULLCompleted18 Years80 YearsAll64Phase 1United States;Canada;United Kingdom;Netherlands
33NCT03658135
(ClinicalTrials.gov)
September 12, 201813/8/2018BIIB092 in Primary Tauopathies: CBS, nfvPPA, sMAPT, and TESA Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel Cohort Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of Intravenously Infused BIIB092 in Patients With Four Different Primary Tauopathy SyndromesPrimary Tauopathies;Corticobasal Degeneration Syndrome;Frontotemporal Lobar Degeneration With Tau Inclusions;MAPT Mutation Carriers, Symptomatic;Traumatic Encephalopathy Syndrome;Nonfluent Aphasia, ProgressiveDrug: BIIB092;Other: PlaceboUniversity of California, San FranciscoNULLTerminated35 Years80 YearsAll22Phase 1United States
34NCT03510572
(ClinicalTrials.gov)
June 4, 201817/4/2018Evaluation of [18F]PI-2620 as a Potential Positron Emission Computed Tomography Radioligand for Imaging Tau Protein in the BrainClinical Evaluation of [18F]PI-2620 Positron Emission Computed Tomography for Imaging Tau Protein in Patients With Tauopathies and Healthy Volunteers: Phase 0 StudyHealthy Volunteer;Alzheimer Disease;Frontotemporal Dementia;Parkinson DiseaseDrug: [18F]PI-2620Asan Medical CenterKorea Health Industry Development InstituteCompleted40 Years80 YearsAll20Early Phase 1Korea, Republic of
35NCT03260920
(ClinicalTrials.gov)
January 31, 201819/7/2017Intranasal Oxytocin for Frontotemporal DementiaA Phase 2 Clinical Trial of Intranasal Oxytocin for Frontotemporal DementiaFrontotemporal DementiaDrug: SyntocinonLawson Health Research InstituteWeston Brain Institute;Canadian Institutes of Health Research (CIHR);Berry ConsultantsRecruiting30 Years80 YearsAll112Phase 2United States;Canada
36NCT03625128
(ClinicalTrials.gov)
January 2, 201812/7/201818F-PM-PBB3 PET Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal ControlsPhase 0 Evaluation of Clinical and Neuroimage (18F-PM-PBB3 PET) Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal ControlsAlzheimer's Disease;Cortical Basal Syndrome;Frontotemporal Dementia;Progressive Supranuclear Palsy;Vascular Cognitive ImpairmentDrug: F-18Chang Gung Memorial HospitalNULLCompleted20 Years90 YearsAll36Early Phase 1Taiwan
37NCT02707978
(ClinicalTrials.gov)
September 30, 20177/4/2015F 18 T807 Tau PET Imaging of Frontotemporal Dementia (FTD)F 18 T807 Tau PET Imaging of Frontotemporal DementiaAlzheimer DiseaseDrug: F 18 T807Tammie L. S. Benzinger, MD, PhDNULLWithdrawn18 YearsN/AAll0Phase 2United States
38NCT03272230
(ClinicalTrials.gov)
September 6, 20173/8/2017Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based SystemAssessment of Apathy in a Real-life Situation, With a Video and Sensors-based System in Healthy Subject and Patient With Cerebral DiseaseApathy;Frontotemporal Dementia;Parkinson Disease;Depressive SymptomsBehavioral: ECOCAPTURE;Behavioral: Cognitive and Behavioral experimental tasks;Diagnostic Test: Neuropsychological assessment;Behavioral: ICM_APATHY_TASKS;Other: MRI;Biological: Neurohormonal mechanisms;Diagnostic Test: Supplementary Neuropsychological Assessment - Parkinson's DiseaseInstitut National de la Santé Et de la Recherche Médicale, FranceNULLRecruiting40 Years85 YearsAll135N/AFrance
39NCT03545126
(ClinicalTrials.gov)
August 21, 201712/3/2018Human CNS Tau Kinetics in TauopathiesHuman CNS Tau Kinetics in TauopathiesProgressive Supranuclear Palsy (PSP);Corticobasal Degeneration (CBD);Frontotemporal Dementia (FTD MAPT Mutation)Other: 13C6 LeucineWashington University School of MedicineAssociation of Frontotemporal Degeneration;Tau ConsortiumActive, not recruiting18 YearsN/AAll32United States
40NCT03174938
(ClinicalTrials.gov)
May 15, 201728/5/2017The Swedish BioFINDER 2 StudyThe Swedish BioFINDER 2 StudyDementia;Alzheimer Disease;Parkinson Disease;Lewy Body Disease;Parkinson-Dementia Syndrome;Frontotemporal Degeneration;Semantic Dementia;Progressive Nonfluent Aphasia;Progressive Supranuclear Palsy;Corticobasal Degeneration;Multiple System Atrophy;Mild Cognitive ImpairmentDiagnostic Test: Flutemetamol F18 Injection;Diagnostic Test: [18F]-RO6958948;Diagnostic Test: Elecsys (Roche) Abeta42, Ttau and Ptau;Diagnostic Test: Lumipulse (Fujirebio) Abeta42, Ttau and PtauSkane University HospitalLund UniversityRecruiting20 Years100 YearsAll1505N/ASweden
41NCT03040713
(ClinicalTrials.gov)
April 11, 201731/1/2017Flortaucipir PET Imaging in Subjects With FTD18F-AV-1451 PET Imaging in Subjects With Frontotemporal DementiaFrontotemporal DementiaDrug: Flortaucipir F18;Procedure: Brain PET scanAvid RadiopharmaceuticalsNULLCompleted18 YearsN/AAll16Phase 1United States
42EUCTR2017-000094-36-SE
(EUCTR)
31/03/201730/01/2017The BioFINDER 2 study - improved diagnostics and increased understanding of the underlying mechanisms of cognitive disordersThe BioFINDER 2 study - improved diagnostics and increased understanding of the pathophysiology of cognitive disorders Neurodegenerative disorders with Tau-pathology; including, but not limited to, Alzheimers disease, progressive supranuclear palsy,frontotemporal dementia, corticobasal degeneration and mild cognitive impairment.
MedDRA version: 19.1;Level: PT;Classification code 10053643;Term: Neurodegenerative disorder;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.1;Classification code 10012267;Term: Dementia;Classification code 10067889;Term: Dementia with Lewy bodies;Level: HLGT;Classification code 10028037;Term: Movement disorders (incl parkinsonism);Classification code 10012271;Term: Dementia Alzheimer's type;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes);Level: LLT;Classification code 10009846;Term: Cognitive impairment;Classification code 10048598;Term: Cognitive disorders;Classification code 10001896;Term: Alzheimer's disease;Classification code 10012285;Term: Dementia due to Pick's disease;Classification code 10036813;Term: Progressive supranuclear palsy;Classification code 10074616;Term: Prodromal Alzheimer's;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Product Name: 18F-RO6958948
Trade Name: Vizamyl (flutemetamol(F-18))
Product Name: Vizamyl
Skåne University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Sweden
43NCT02862210
(ClinicalTrials.gov)
January 27, 20177/8/2016Low-Dose Lithium for the Treatment of Behavioral Symptoms in Frontotemporal DementiaLow-Dose Lithium for the Treatment of Behavioral Symptoms in Frontotemporal DementiaFrontotemporal Dementia (FTD)Drug: Lithium Carbonate;Drug: PlaceboColumbia UniversityAlzheimer's Drug Discovery FoundationRecruiting40 Years85 YearsAll60Phase 2United States
44EUCTR2015-005604-29-NL
(EUCTR)
16/11/201620/01/2016Imaging of tau in patients with dementiaTau-imaging in tauopathies; Alzheimer’s disease and non-AD dementias - TITAN Dementia inducing Alzheimer's disease, Frontotemporal dementia (FTD) and Lewy Body Dementia (DLB)
MedDRA version: 20.0;Level: PT;Classification code 10012271;Term: Dementia Alzheimer's type;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10057095;Term: Diffuse Lewy body disease;System Organ Class: 100000072901
MedDRA version: 20.0;Classification code 10068968;Term: Frontotemporal dementia;Classification code 10012283;Term: Dementia due to other general medical conditions;System Organ Class: 100000014717;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 18F-AV-1451
INN or Proposed INN: not applicable
Other descriptive name: T807
VU University Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Netherlands
45NCT02676843
(ClinicalTrials.gov)
April 201615/1/2016Tau PET Imaging With 18F-AV-1451 in Subjects With MAPT MutationsTau PET Imaging With 18F-AV-1451 in Subjects With MAPT MutationsFrontotemporal Lobar Degeneration (FTLD);Frontotemporal Dementia (FTD);TauopathiesDrug: 18F-AV-1451Columbia UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Completed18 YearsN/AAll7Phase 2United States
46EUCTR2014-002013-37-NL
(EUCTR)
24/03/201613/07/2015An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trialAn Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia Alzheimer’s Disease and behavioral variant Frontotemporal Dementia
MedDRA version: 19.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
966Phase 3United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
47EUCTR2014-002013-37-BE
(EUCTR)
03/06/201531/03/2015An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trialAn Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia Alzheimer’s Disease and behavioral variant Frontotemporal Dementia
MedDRA version: 18.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.1;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
1400Phase 3United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
48EUCTR2014-002013-37-FI
(EUCTR)
11/05/201525/03/2015An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trialAn Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia Alzheimer’s Disease and behavioral variant Frontotemporal Dementia
MedDRA version: 19.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
966Phase 3United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Belgium;Malaysia;Singapore;Romania;Croatia;Australia;Netherlands;Germany;Korea, Republic of
49EUCTR2014-001489-85-BE
(EUCTR)
05/03/201524/10/2014A study to investigate 2 doses of investigational drug on patients with Prodromal to Moderate Frontotemporal Dementia with Granulin MutationA Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects with Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation
MedDRA version: 18.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: FRM-0334
INN or Proposed INN: Histone Deacetylase Inhibitor
Other descriptive name: EVP-0334
FORUM Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
30Phase 2France;United States;Belgium;Netherlands;Italy;United Kingdom
50EUCTR2014-002013-37-HR
(EUCTR)
04/03/201531/03/2015An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trialAn Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia Alzheimer’s Disease and behavioral variant Frontotemporal Dementia
MedDRA version: 19.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
966Phase 3United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Argentina;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
51EUCTR2014-001489-85-GB
(EUCTR)
23/02/201512/08/2014A study to investigate 2 doses of investigational drug on patients with Prodromal to Moderate Frontotemporal Dementia with Granulin MutationA Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects with Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation
MedDRA version: 18.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: FRM-0334
INN or Proposed INN: Histone Deacetylase Inhibitor
Other descriptive name: EVP-0334
FORUM Pharmaceuticals Inc.NULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Belgium;Netherlands;Italy;United Kingdom
52EUCTR2014-002013-37-ES
(EUCTR)
13/02/201516/12/2014An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trialAn Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer?s Disease or Behavioral Variant Frontotemporal Dementia Alzheimer?s Disease and behavioral variant Frontotemporal Dementia
MedDRA version: 17.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.1;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
1400Phase 3United States;Taiwan;Finland;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Argentina;Poland;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
53EUCTR2014-001489-85-IT
(EUCTR)
22/12/201402/10/2014A study to investigate 2 doses of investigational drug on patients with Prodromal to Moderate Frontotemporal Dementia with Granulin MutationA Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects with Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation
MedDRA version: 17.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: FRM-0334
INN or Proposed INN: Histone Deacetylase Inhibitor
Other descriptive name: EVP-0334
FORUM Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
30Phase 2France;United States;Belgium;Netherlands;United Kingdom;Italy
54EUCTR2014-001489-85-NL
(EUCTR)
19/12/201423/09/2014A study to investigate 2 doses of investigational drug on patients with Prodromal to Moderate Frontotemporal Dementia with Granulin MutationA Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects with Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation
MedDRA version: 18.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: FRM-0334
INN or Proposed INN: Histone Deacetylase Inhibitor
Other descriptive name: EVP-0334
FORUM Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
30Phase 2France;United States;Belgium;Netherlands;Italy;United Kingdom
55EUCTR2014-001315-40-IT
(EUCTR)
03/12/201410/10/2014Florbetapir-PET scan in subjects with a known mutation for autosomal dominant Alzheimer's Disease taking part in the ItalianDIAfN studyAmyloid Imaging in the Italian Network for autosomal dominant Alzheimer’s disease and frontotemporal lobar degeneration (ItalianDIAfN)” - Amyloid-PET in ItalianDIAfN Autosomal Dominant Alzheimer's Disease
MedDRA version: 17.0;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Amyvid
Product Name: Florbetapir (18F)
Product Code: Florbetapir (18F)
INN or Proposed INN: florbetapir (18F)
Other descriptive name: N/A
IRCCS Istituto Centro San Giovanni di Dio FatebenefratelliNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
56EUCTR2014-002013-37-GB
(EUCTR)
06/10/201420/08/2014An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trial An Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia Alzheimer’s Disease and behavioral variant Frontotemporal Dementia
MedDRA version: 19.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot Recruiting Female: yes
Male: yes
966 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
57NCT02149160
(ClinicalTrials.gov)
October 201420/5/2014Study to Assess the Safety, Tolerability, and Pharmacodynamic (PD) Effects of FRM-0334 in Subjects With Prodromal to Moderate Frontotemporal Dementia With Granulin MutationA Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects With Prodromal to Moderate Frontotemporal Dementia With Granulin MutationGranulin MutationDrug: FRM-0334;Drug: PlaceboFORUM Pharmaceuticals IncNULLActive, not recruiting21 Years75 YearsBoth30Phase 2United States;Belgium;France;Italy;Netherlands;United Kingdom
58EUCTR2014-000422-38-SE
(EUCTR)
19/09/201405/08/2014A study evaluating the diagnostic accuracy of [18F]-AV-1451 PET to detect and distinguish neurodegenerative disorders characterized by cerebral accumulation of the protein tauAn open-label study evaluating the diagnostic accuracy of [18F]-AV-1451 PET to detect and distinguish neurodegenerative disorders characterized by cerebral accumulation of tau Neurodegenerative disorders with Tau-pathology; including Alzheimer's disease, progressive supranuclear palsy, frontotemporal dementia, corticobasal degeneration and important differential diagnostic conditions.
MedDRA version: 17.0;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes);System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.0;Level: PT;Classification code 10053643;Term: Neurodegenerative disorder;Level: LLT;Classification code 10009846;Term: Cognitive impairment;Classification code 10001896;Term: Alzheimer's disease;Classification code 10012285;Term: Dementia due to Pick's disease;Classification code 10012267;Term: Dementia;Classification code 10067889;Term: Dementia with Lewy bodies;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Product Name: 18F-AV-1451Skåne University Hospital, Region SkåneNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Sweden
59NCT02245568
(ClinicalTrials.gov)
August 201427/8/2014Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)An Open-Label, Extension Study of the Effects of LMTM in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)Alzheimer's Disease;Behavioral Variant Frontotemporal DementiaDrug: LMTMTauRx Therapeutics LtdNULLTerminatedN/AN/AAll913Phase 3United States;Australia;Belgium;Canada;Croatia;Finland;France;Germany;Korea, Republic of;Malaysia;Netherlands;Romania;Russian Federation;Singapore;Spain;Taiwan;United Kingdom;Argentina;Bulgaria;Italy;Poland
60EUCTR2011-005529-34-PL
(EUCTR)
11/06/201411/03/2014A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementiaA Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 behavioral variant Frontotemporal Dementia (bvFTD)
MedDRA version: 18.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Finland;Spain;United Kingdom;Italy;Canada;Poland;Singapore;Croatia;Romania;Australia;Germany;Netherlands
61EUCTR2011-005529-34-ES
(EUCTR)
07/05/201401/04/2014A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementiaA Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 behavioral variant Frontotemporal Dementia (bvFTD)
MedDRA version: 16.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N?,N?-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Canada;Finland;Poland;Spain;Singapore;Croatia;Australia;Netherlands;Germany;Italy;United Kingdom
62EUCTR2011-005529-34-HR
(EUCTR)
14/04/201403/09/2014A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementiaA Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 behavioral variant Frontotemporal Dementia (bvFTD)
MedDRA version: 18.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United Kingdom;Italy;Canada;Poland;Singapore;Croatia;Romania;Australia;Germany;Netherlands;United States;Finland;Spain
63EUCTR2011-005529-34-FI
(EUCTR)
04/04/201419/02/2014A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementiaA Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 behavioral variant Frontotemporal Dementia (bvFTD)
MedDRA version: 17.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Canada;Finland;Spain;Poland;Singapore;Croatia;Australia;Netherlands;Germany;Italy;United Kingdom
64EUCTR2011-005529-34-IT
(EUCTR)
06/02/201430/12/2013A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementiaA Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 behavioral variant Frontotemporal Dementia (bvFTD)
MedDRA version: 16.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Canada;Finland;Spain;Poland;Singapore;Croatia;Australia;Netherlands;Germany;United Kingdom;Italy
65NCT01937013
(ClinicalTrials.gov)
September 12, 20133/9/2013Impact of Emotional Mimicry and Oxytocin on Frontotemporal DementiaImpact of Emotional Mimicry and Oxytocin on Frontotemporal DementiaFrontotemporal DementiaDrug: Intranasal oxytocin;Drug: Saline Nasal MistLawson Health Research InstituteCanadian Institutes of Health Research (CIHR)Completed30 Years85 YearsAll52Phase 2Canada
66EUCTR2011-005529-34-NL
(EUCTR)
24/06/201309/08/2012A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementiaA Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 behavioral variant Frontotemporal Dementia (bvFTD)
MedDRA version: 17.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Canada;Finland;Spain;Poland;Singapore;Croatia;Australia;Germany;Netherlands;Italy;United Kingdom
67NCT01626378
(ClinicalTrials.gov)
May 201320/6/2012Safety and Efficacy Study Evaluating TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)Behavioral Variant Frontotemporal Dementia (bvFTD)Drug: TRx0237;Drug: PlaceboTauRx Therapeutics LtdNULLCompletedN/A79 YearsAll220Phase 3United States;Australia;Canada;Croatia;Germany;Italy;Netherlands;Poland;Romania;Singapore;Spain;United Kingdom;Argentina;Bulgaria;Finland
68EUCTR2012-004328-40-IT
(EUCTR)
01/03/201323/11/2012study of neuroinflammation in pathologies like Alzheimer, mild cognitive impairment, dementia and SLAIMAGING OF NEUROINFLAMMATION IN NEURODEGENERATIVE DISEASES mild cognitive impairment, Alzheimer disease,frontotemporal dementia, SLA
MedDRA version: 14.1;Level: LLT;Classification code 10050727;Term: RI scan;System Organ Class: 100000004848;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: NA
Product Code: (R)-[N-metil-11C1-PK11195(PK)
OSPEDALE S. RAFFAELE DI MILANONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
69EUCTR2011-005529-34-GB
(EUCTR)
17/01/201308/08/2012A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementiaA Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 behavioral variant Frontotemporal Dementia (bvFTD)
MedDRA version: 18.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Finland;Spain;United Kingdom;Italy;Canada;Poland;Singapore;Croatia;Romania;Australia;Germany;Netherlands
70EUCTR2011-005529-34-DE
(EUCTR)
28/12/201208/08/2012A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementiaA Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 behavioral variant Frontotemporal Dementia (bvFTD)
MedDRA version: 18.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Finland;Spain;United Kingdom;Italy;Canada;Poland;Singapore;Croatia;Romania;Australia;Germany;Netherlands
71EUCTR2011-004571-37-IT
(EUCTR)
21/02/201217/02/2012Amiodarone therapy for treatment of fontotemporat dementia caused by progranulin deficiency- Rescue of Progranulin HaploInsufficiency in Frontotemporal Dementia - ReProIn-FTD frontotemporal dementia associated to progranulin deficit
MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
INN or Proposed INN: AMIODARONE
Other descriptive name: NA
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
72NCT00604591
(ClinicalTrials.gov)
July 201119/1/2008Effects of Tolcapone on Frontotemporal DementiaInvestigation of the Dopamine System in Frontotemporal DementiaFrontotemporal Lobar DegenerationDrug: Tolcapone;Drug: PlaceboColumbia UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Completed40 Years85 YearsAll28Phase 2United States
73NCT01386333
(ClinicalTrials.gov)
June 201129/6/2011Safety Study of Intranasal Oxytocin in Frontotemporal DementiaA Phase I Dose Finding Study of Intranasal Oxytocin in Frontotemporal Dementia, Protocol # FTDOXY10EFFrontotemporal DementiaDrug: oxytocin;Drug: Saline Nasal MistLawson Health Research InstituteThe Consortium of Canadian Centres for Clinical Cognitive Research (C5R)Completed30 Years80 YearsBoth23Phase 1Canada
74JPRN-UMIN000003683
2010/06/0131/05/2010The efficacy of ferulic acid in the treatment of dementia Alzheimer's Disease, Dementia of Lewy Body,Vascular Dementia, Frontotemporal DementiaTaking of Ferulic Acid for 6 months followed by Not taking of Ferulic Acid for 6 months.

Not taking of Ferulic Acid for 6 months followed by taking of Ferulic Acid for 6 months.
Shimane University HospitalNULLComplete: follow-up complete20years-old90years-oldMale and Female50Not selectedJapan
75NCT01623284
(ClinicalTrials.gov)
March 20107/6/2012PiB PET Scanning in Speech and Language Based DementiasPiB PET Scanning in Speech and Language Based DementiasPPA;Primary Progressive Aphasia;Aphasia;Non-fluent Aphasia;Semantic Dementia;Apraxia of Speech;Primary Progressive Nonfluent Aphasia;Progressive AphasiaDrug: C-11 PiB;Drug: F-18 FDGMayo ClinicNULLCompleted18 YearsN/ABoth168Phase 1United States
76NCT01056965
(ClinicalTrials.gov)
January 201021/1/2010Davunetide (AL-108) in Predicted Tauopathies - Pilot StudyA 12 Week Randomized, Double Blind, Placebo-Controlled Pilot Study of Davunetide (NAP, AL-108) in Predicted TauopathiesPredicted Tauopathies, Including;Progressive Supranuclear Palsy;Frontotemporal Dementia With Parkinsonism Linked to Chromosome 17;Corticobasal Degeneration Syndrome;Progressive Nonfluent AphasiaDrug: davunetide (AL-108, NAP);Drug: Placebo nasal sprayUniversity of California, San FranciscoNULLCompleted40 Years85 YearsAll12Phase 1United States
77NCT01890343
(ClinicalTrials.gov)
September 200927/6/2013Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls.A Study Evaluating the Imaging Characteristics of Florbetapir 18F (18F-AV-45) in Patients With Frontotemporal Dementia Compared to Patients With Alzheimer's Disease and Normal Controls.Alzheimer's Disease;Frontotemporal DementiaDrug: florbetapir 18F;Drug: 18F-FDGAvid RadiopharmaceuticalsNULLCompleted45 YearsN/AAll34Phase 2United Kingdom
78NCT01002300
(ClinicalTrials.gov)
September 200923/10/2009Oxytocin and Social Cognition in Frontotemporal DementiaInvestigation of the Effects of Intranasal Oxytocin on Cognition and Emotion Processing in Frontotemporal DementiaFrontotemporal Dementia;Pick's DiseaseDrug: intranasal oxytocinLawson Health Research InstituteThe Alzheimer Society London and MiddlesexCompleted30 Years80 YearsBoth24N/ACanada
79EUCTR2008-003597-18-GB
(EUCTR)
28/05/200914/04/2009Amyloid imaging in Alzheimer’s disease, frontotemporal dementia and healthy volunteersA study evaluating the imaging characteristics of 18F-AV-45 in patients with frontotemporal dementia compared to patients with Alzheimer's disease and normal controls Use of 18F-AV-45 positron emission tomography as early diagnostic technique in frontal lobe dementia and Alzheimer's disease.
MedDRA version: 14.0;Level: PT;Classification code 10061816;Term: Diagnostic procedure;System Organ Class: 10022891 - Investigations
Product Name: florbetapir 18F
Product Code: 18F-AV-45
Other descriptive name: florbetapir 18F Injection
Avid Radiopharmaceuticals, IncNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
80NCT00950430
(ClinicalTrials.gov)
April 200829/7/2009Imaging of Brain Amyloid Plaques in the Aging PopulationBrain Amyloid Imaging With Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and DementiaAlzheimer's Disease;Dementia With Lewy Bodies;Frontotemporal Dementia;Vascular DementiaDrug: Pittsburgh Compound B (C-11 PiB);Drug: F-18 FDG;Drug: Tau (18-F-AV-1451)Mayo ClinicNational Institute on Aging (NIA)Enrolling by invitation30 Years100 YearsAll5000Phase 4United States
81JPRN-UMIN000003239
2008/01/0123/02/2010Influence of donepezil to behavioral and psychological symptoms of frontotemporal dementia Frontotemporal dementiaDiscontinuation of donepezilNational Hospital Organization Kikuchi HospitalNULLComplete: follow-up complete50years-old90years-oldMale and Female25Not selectedJapan
82NCT00594737
(ClinicalTrials.gov)
October 20077/1/2008Open Label Pilot Study of the Effects of Memantine on FDG-PET in Frontotemporal DementiaAn Open Label Pilot Study of the Effects of Memantine Administration on FDG-PET in Frontotemporal DementiaFrontotemporal DementiaDrug: memantine hydrochlorideTiffany Chow, MDH. Lundbeck A/SCompleted40 Years80 YearsBoth17Phase 3Canada
83NCT00545974
(ClinicalTrials.gov)
October 200716/10/2007Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal DementiaA Prospective, Randomized, Multi-Center, Double-Blind, 26 Week, Placebo-Controlled Trial of Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal DementiaFrontal Lobe Dementia;Frontotemporal Lobe Dementia;Semantic DementiaDrug: memantine;Drug: Placebo pillUniversity of California, San FranciscoForest LaboratoriesCompleted40 Years80 YearsAll81Phase 4United States
84NCT00376051
(ClinicalTrials.gov)
September 200613/9/2006Serotonergic Function and Behavioural and Psychological Symptoms of Frontotemporal DementiaSerotonergic Function and Behavioural and Psychological Symptoms of Frontotemporal DementiaFrontotemporal DementiaDrug: CitalopramSunnybrook Health Sciences CentreAlzheimer Society of CanadaCompleted18 YearsN/AAll22Phase 4Canada
85EUCTR2005-005915-13-GB
(EUCTR)
12/07/200610/04/2006An Open Pilot Study of Methlythioninium Chloride (MTC) in Frontotemporal Dementia and Related Dementia Syndromes - Pilot Stidy of MTC in FTD and related dementia syndromesAn Open Pilot Study of Methlythioninium Chloride (MTC) in Frontotemporal Dementia and Related Dementia Syndromes - Pilot Stidy of MTC in FTD and related dementia syndromes Frontotemporal Dementia and related syndromes Prevention and reversal of tau protein aggregation is a novel approach to the treatment of patients with FTD and related syndromes and has the potential for slowing the disease process as well as providing symptomatic improvement in hitherto untreatable, ultimately fatal conditions.
MedDRA version: 8.1;Level: PT;Classification code 10012267
Product Name: Methylthioninium chloride
Product Code: MTC TRx0014-001 capsules
TauRx Therapeutics PTE LtdNULLNot RecruitingFemale: yes
Male: yes
20Phase 2United Kingdom
86NCT00127114
(ClinicalTrials.gov)
September 20053/8/2005Amantadine for the Treatment of Behavioral Disturbance in Frontotemporal Dementia (FTD)Amantadine for the Treatment of Behavioral Disturbance in Frontotemporal Dementia (FTD)DementiaDrug: Amantadine;Drug: PlaceboJohns Hopkins UniversityNULLWithdrawn40 Years90 YearsAll0Phase 4United States
87NCT00200538
(ClinicalTrials.gov)
September 200512/9/2005Efficacy and Tolerability of Memantine in Frontotemporal Dementia (FTD) PatientsDouble-blind, Parallel Group, Placebo-controlled Trial of the Efficacy and Tolerability of Memantine (20 mg) in Frontotemporal Dementia (FTD) PatientsDementiaDrug: memantineNantes University HospitalNULLCompleted45 Years75 YearsBoth52Phase 2France
88NCT00187525
(ClinicalTrials.gov)
May 200413/9/2005A 52 Week Open Label Trial of Memantine for Frontotemporal Lobar DegenerationFrontotemporal Lobar DegenerationDrug: MemantineUniversity of California, San FranciscoForest LaboratoriesCompleted40 Years80 YearsBothPhase 4NULL
89NCT00416169
(ClinicalTrials.gov)
May 200322/12/2006A Pilot Study to Explore the Safety and Tolerability of Galantamine HBr in the Treatment of Pick Complex/Frontotemporal DementiaAn Open Pilot Study to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Pick's Disease/Frontotemporal Dementia /Pick ComplexFrontotemporal Dementia;Pick ComplexDrug: galantamine hydrobromideJohnson & Johnson Pharmaceutical Research & Development, L.L.C.NULLCompleted30 Years80 YearsBoth41Phase 2NULL