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AL001 for Frontotemporal Dementia

Start: July 23, 2020
End: December 30, 2023
Enrollment: 180

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?

Minimum Age: 25 Years

Maximum Age: 85 Years

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 unresolved cancer
  • 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.

 
Study Contact
Study Lead

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

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
Colorado
University of Colorado
Aurora, CO 80045
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