AL001 for Frontotemporal Dementia

What Is This Study About?

This Phase 3 study will evaluate the safety and effects of the experimental drug AL001 in people with or at risk for frontotemporal dementia (FTD) due to a mutation in the progranulin gene. Participants will be randomly assigned to receive AL001 or a placebo by injection every four weeks. At the start of the study and at 48 weeks, participants will provide blood samples and cerebrospinal samples (optional), and undergo MRI brain scans. Researchers will also measure changes in memory, function (e.g., personal care, language), and behavior. Researchers will monitor for safety and drug effects throughout the study for up to 96 weeks. 

Do I Qualify To Participate in This Study?

Must have:

• Progranulin gene mutation with a diagnosis of FTD or at risk of developing FTD symptoms based on other clinical testing
• If experiencing FTD symptoms, meet the criteria for the diagnosis of probable behavioral variant, semantic, or progressive non-fluent aphasia FTD
• Availability of study partner who agrees to study participation and who cares for or visits the person with FTD daily for at least five hours per week

Must NOT have:

• Dementia due to a condition other than FTD (e.g., Alzheimer's disease, Parkinson's disease, Lewy body dementia, Huntington's disease, or vascular dementia)
• History or evidence of clinically significant brain disease other than FTD
• History of cancer within the last five years
• Current uncontrolled high blood pressure, diabetes, or thyroid disease
• Clinically significant heart disease, liver disease, or kidney disease
• Known history of severe allergic reaction or hypersensitivity to chimeric, human, or humanized antibodies or fusion proteins
• History of receiving any experimental vaccine or gene therapy
• Current use of blood thinner medication (e.g., coumadin, heparinoids, apixaban)
• If female, currently or planning to be pregnant or breastfeeding within the study period
• Living in a skilled nursing facility, convalescent home, or long-term care facility, or require continuous nursing care

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Where Is This Study Located?

Arizona
Dignity Health Phoenix, AZ 85013 Recruiting Study Coordinator
California
University of California San Diego La Jolla, CA 92093-0648 Recruiting Study Coordinator
University of California San Francisco San Francisco, CA 94143 Not yet recruiting Study Coordinator
Florida
University of Miami Medical Center Miami, FL 33136 Recruiting Study Coordinator
Georgia
Emory University Atlanta, GA 30329 Recruiting Study Coordinator
Illinois
Northwestern University Evanston, IL 60611 Recruiting Study Coordinator
Indiana
Indiana University Health Neuroscience Center Indianapolis, IN 46202 Recruiting Study Coordinator
Kansas
University of Kansas Alzheimer's Disease Center Fairway, KS 66205 Recruiting Study Coordinator
Maryland
Johns Hopkins University School of Medicine Baltimore, MD 21205 Recruiting Study Coordinator
Minnesota
Mayo Comprehensive Cancer Center - PPDS Rochester, MN 55905 Recruiting Study Coordinator
New York
Irving Institute for Clinical and Translational Research New York, NY 10032 Recruiting Study Coordinator
North Carolina
University of North Carolina at Chapel Hill Chapel Hill, NC 27599-7025 Recruiting Study Coordinator
Ohio
University Of Cincinnati Gardner Neuroscience institute Cincinnati, OH 45219 Recruiting Study Coordinator
Case Western Reserve University Cleveland, OH 44106 Recruiting Study Coordinator
Oregon
Oregon Health and Science University Portland, OR 97239 Recruiting Study Coordintaor
Pennsylvania
University of Pennsylvania Philadelphia, PA 19104 Recruiting Study Coordinator
Tennessee
Vanderbilt University Medical Center Nashville, TN 37232 Recruiting Study Coordinator
Texas
Houston Methodist Institute for Academic Medicine Houston, TX 77030 Recruiting Study Coordinator
University of Texas Health Science Center at San Antonio San Antonio, TX 78229 Recruiting Study Coordinator
Wisconsin
Froedtert and The Medical College of Wisconsin Milwaukee, WI 53226 Recruiting Study Coordinator

Who Sponsors This Study?

Lead: Alector Inc.

Source: ClinicalTrials.gov ID: NCT04374136