NCT03987295CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 5 Dec 2025
Brief summary (registry, in English)
A Phase 2 open label study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AL001 in participants with a Granulin mutation or C9orf72 mutation causative of frontotemporal dementia.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 14 May 2019
- Start date
- 27 Sept 2019
- Primary completion date
- 5 Jun 2024
- Lead sponsor
- Alector Inc.
- Diseases
- Frontotemporal dementia
- NCT number
- NCT03987295
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 33
- From 27 Sept 2019 to the primary completion date, 5 Jun 2024
- 12 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
- History of alcohol abuse or substance abuse
Other
- Participant resides in a skilled nursing facility, convalescent home, or long term care facility
Who the study is looking for
- At screening, female participants must be nonpregnant and nonlactating
- In good physical health on the basis of no clinically significant findings from medical history, physical examinations (PEs), laboratory tests, ECGs, and vital signs.
- Participant is a carrier of a loss of function progranulin gene (GRN) mutation or carrier of a hexanucleotide repeat expansion C9orf72 mutation
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lawson Health Research Institute, St. Joseph's Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Technical University of Munich Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| University of Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
| University College London Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University of Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| Brain Research Center - PPDS Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Erasmus University Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| The Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases UT Health San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| UCSF Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.