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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-004066-18-FR (EUCTR) | 04/02/2021 | 30/06/2020 | A 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 | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 2 | EUCTR2019-004066-18-GB (EUCTR) | 03/12/2020 | 25/09/2020 | A 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 | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Portugal;United States;Spain;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 3 | EUCTR2019-004066-18-SE (EUCTR) | 06/10/2020 | 10/06/2020 | A 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 | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 4 | EUCTR2019-004066-18-NL (EUCTR) | 02/09/2020 | 03/03/2020 | A 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 | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 5 | EUCTR2019-004066-18-BE (EUCTR) | 31/07/2020 | 26/05/2020 | A 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 | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 6 | NCT04374136 (ClinicalTrials.gov) | July 23, 2020 | 23/4/2020 | A 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 Gene | Frontotemporal Dementia | Drug: AL001;Drug: Placebo;Drug: Open label - AL001 | Alector Inc. | NULL | Recruiting | 25 Years | 85 Years | All | 180 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Portugal;Spain;Sweden;Switzerland;United Kingdom |
| 7 | EUCTR2019-004066-18-DE (EUCTR) | 06/07/2020 | 20/02/2020 | A 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 | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Portugal;United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 8 | EUCTR2019-004066-18-PT (EUCTR) | 29/05/2020 | 21/02/2020 | A 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 | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Portugal;United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 9 | EUCTR2019-004066-18-IT (EUCTR) | 18/05/2020 | 15/06/2021 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Germany;Netherlands;Sweden;United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia | ||
| 10 | EUCTR2019-004066-18-ES (EUCTR) | 22/04/2020 | 06/03/2020 | A 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 | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Portugal;France;Canada;Belgium;Spain;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 11 | EUCTR2019-000138-20-GB (EUCTR) | 18/11/2019 | 21/05/2019 | An Open-Label Study to Evaluate Safety of long-term AL001 dosing in FTD | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 2 | United States;Canada;Netherlands;Germany;Italy;United Kingdom | ||
| 12 | EUCTR2019-000138-20-DE (EUCTR) | 08/10/2019 | 27/05/2019 | An Open-Label Study to Evaluate Safety of long-term AL001 dosing in FTD | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United States;Canada;Netherlands;Germany;United Kingdom;Italy | ||
| 13 | NCT03987295 (ClinicalTrials.gov) | September 27, 2019 | 14/5/2019 | A 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 Dementia | Frontotemporal Dementia | Drug: AL001 | Alector Inc. | NULL | Recruiting | 18 Years | 85 Years | All | 40 | Phase 2 | United States;Canada;Germany;Italy;Netherlands;United Kingdom |
| 14 | EUCTR2019-000138-20-IT (EUCTR) | 24/09/2019 | 15/01/2021 | An Open-Label Study to Evaluate Safety of long-term AL001 dosing in FTD | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 2 | United States;Canada;Netherlands;Germany;United Kingdom;Italy | ||
| 15 | EUCTR2019-000138-20-NL (EUCTR) | 20/09/2019 | 06/06/2019 | An Open-Label Study to Evaluate Safety of long-term AL001 dosing in FTD | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United States;Canada;Germany;Netherlands;United Kingdom;Italy | ||
| 16 | NCT03636204 (ClinicalTrials.gov) | September 14, 2018 | 12/7/2018 | A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) Mutation | A First in Human Phase 1 Study in Healthy Volunteers and in Participants With Frontotemporal Dementia (FTD) With Granulin Mutation | Healthy;Frontotemporal Dementia | Biological: AL001;Other: Placebo | Alector Inc. | NULL | Completed | 18 Years | 80 Years | All | 64 | Phase 1 | United States;Canada;United Kingdom;Netherlands |