A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Frontotemporal Dementia

In brief

A phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranulin gene.

Key facts

Study ID: NCT04374136
Run by: Alector Inc.
People needed: 119
Starts: 2020-07-23
Expected to finish: 2026-01-06
Last updated by the study team: 2026-01-21

Who can join

Age: 25 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Persons with a progranulin gene mutation and at risk of developing FTD symptoms as evidenced by a biomarker, or persons with a progranulin gene mutation and diagnosed with FTD.
If symptomatic, one or more of the criteria for the diagnosis of possible behavioral variant FTD, or a diagnosis of Primary Progressive Aphasia.
Study partner who consents to study participation and who cares for/visits the participant daily for at least 5 hours per week.
Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).

You may not qualify if…

Dementia due to a condition other than FTD including, but not limited to, Alzheimer's disease, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia.
Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
Current uncontrolled hypertension, diabetes mellitus or thyroid disease. Clinically significant heart disease, liver disease or kidney disease. History or evidence of clinically significant brain disease other than FTD.
Females who are pregnant or breastfeeding, or planning to conceive within the study period.
Any experimental vaccine or gene therapy.
History of cancer within the last 5 years.
Current use of anticoagulant medications (e.g., coumadin, heparinoids, apixaban).
Residence in a skilled nursing facility, convalescent home, or long term care facility at screening; or requires continuous nursing care.

Where it is running

Dignity Health — Phoenix, Arizona, United States
University of California San Diego — La Jolla, California, United States
University of Colorado — Aurora, Colorado, United States
Emory University — Atlanta, Georgia, United States
Indiana University Health Neuroscience Center — Indianapolis, Indiana, United States
University of Kansas Alzheimer's Disease Center — Fairway, Kansas, United States
Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
Mayo Comprehensive Cancer Center - PPDS — Rochester, Minnesota, United States
Irving Institute for Clinical and Translational Research — New York, New York, United States
University Of Cincinnati Gardner Neuroscience institute — Cincinnati, Ohio, United States
Oregon Health and Science University — Portland, Oregon, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States
Houston Methodist Institute for Academic Medicine — Houston, Texas, United States
Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia — Buenos Aires, Argentina
Box Hill Hospital — Box Hill, Australia
The Queen Elizabeth Hospital — Woodville, Australia
UZ Leuven — Leuven, Vlaams Brabant, Belgium
The University of Western Ontario — London, Canada
Sunnybrook Research Institute - University of Toronto — Toronto, Canada
CHU de Bordeaux — Bordeaux, France
CHRU Lille — Lille, France
Groupe Hospitalier Pitié Salpétrière — Paris, France
Uniklinik Köln — Cologne, Germany
Universitätsklinikum Ulm — Ulm, Germany

Full record on ClinicalTrials.gov

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