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Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects
Sponsor: Alzheon Inc.
Summary
This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801.
Official title: Long-term Extension of a Phase 3, Multicenter, Randomized, Double-Blind, Placebo- Controlled Study of the Efficacy, Safety, and Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease and APOE4/4 Genotype
Key Details
Gender
All
Age Range
50 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
163
Start Date
2024-04-02
Completion Date
2027-01
Last Updated
2025-10-31
Healthy Volunteers
No
Conditions
Interventions
Experimental: ALZ-801
ALZ-801 265 mg BID tablet orally.
Locations (41)
Xenoscience, Inc.
Phoenix, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
ATP Clinical Research
Costa Mesa, California, United States
Torrance Clinical Research Institute
Lomita, California, United States
Sutter Health
Sacramento, California, United States
JEM Research Institute, Headlands Site
Atlantis, Florida, United States
K2 Medical Research, LLC
Maitland, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Aqualane Clinical Research
Naples, Florida, United States
Charter Research
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
ALZ Research and Treatment Center (A.R.T.C.)
Stuart, Florida, United States
ALZ Research and Treatment Center (A.R.T.C.)
Wellington, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Columbus Memory Center
Columbus, Georgia, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
Headlands Research Eastern MA
Plymouth, Massachusetts, United States
Advanced Memory Research Center
Toms River, New Jersey, United States
Neurological Associates of Albany
Albany, New York, United States
NYU Alzheimer's Disease Research Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Triad Clinical Trials
Greensboro, North Carolina, United States
AMC Research
Matthews, North Carolina, United States
Center for Cognitive Health
Portland, Oregon, United States
Abington Neurological Associates
Abington, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
UT Health Science Center at Houston
Houston, Texas, United States
Re:Cognition Health
Fairfax, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
OCT Research ULC (dba Okanagan Clinical Trials)
Kelowna, British Columbia, Canada
Centricity Research
Halifax, Nova Scotia, Canada
Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic
Ottawa, Ontario, Canada
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, Canada
Toronto Memory Program
Toronto, Ontario, Canada
Re-Cognition Health Ltd Plymouth
Plymouth, Devon, United Kingdom
Re-Cognition Health Ltd London
London, Greater London, United Kingdom
NeuroClin Glasgow Ltd
Motherwell, North Lanarkshire, United Kingdom
Re-Cognition Health Ltd Guildford
Guildford, Surrey, United Kingdom
Re-Cognition Health Ltd Birmingham
Birmingham, West Midlands, United Kingdom
Re-Cognition Health Ltd Bristol
Bristol, United Kingdom
Re-Cognition Health Ltd Winchester
Winchester, United Kingdom