A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)

Completed · Phase 2

Conditions studied: Frontotemporal Dementia

In brief

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.

Key facts

Study ID

NCT03987295

Run by

Alector Inc.

People needed

33

Starts

2019-09-27

Expected to finish

2024-06-05

Last updated by the study team

2025-12-05

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Participant resides in a skilled nursing facility, convalescent home, or long term care facility

Where it is running

• UCSF — San Francisco, California, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• The Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases UT Health San Antonio — San Antonio, Texas, United States
• Lawson Health Research Institute, St. Joseph's — London, Ontario, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• Technical University of Munich — München, Germany
• University of Ulm — Ulm, Germany
• University of Brescia — Brescia, Italy
• Brain Research Center - PPDS — Amsterdam, Netherlands
• Erasmus University Medical Center — Rotterdam, Netherlands
• University College London — London, United Kingdom

Full record on ClinicalTrials.gov

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