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A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)
Sponsor: Alzheimer's Disease Cooperative Study (ADCS)
Summary
The purpose of this study is to learn more about the safety, effectiveness and tolerability of the study drug called Benfotiamine which may delay or slow the progression of the symptoms of early Alzheimer's disease.
Official title: A Seamless Phase 2A-Phase 2B Randomized Double-Blind Placebo- Controlled Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)
Key Details
Gender
All
Age Range
50 Years - 89 Years
Study Type
INTERVENTIONAL
Enrollment
406
Start Date
2024-03-28
Completion Date
2027-12-01
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
Low Dose Benfotiamine
300mg benfotiamine capsules (BID, twice a day)
High Dose Benfotiamine
600mg benfotiamine capsules (BID, twice a day)
Placebo
Placebo capsules to mimic benfotiamine capsules (BID, twice a day)
Locations (47)
St. Joseph's Hospital and Medical Center/Barrow Neurological Institute
Phoenix, Arizona, United States
Perseverance Research Center, LLC
Scottsdale, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
The Neuron Clinic
Chula Vista, California, United States
University of California, Irvine
Irvine, California, United States
Pacific Research Network
Lemon Grove, California, United States
University of Southern California
Los Angeles, California, United States
Cedars Sinai, Los Angeles
Los Angeles, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
JEM Research Institute
Atlantis, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
CCM Clinical Research Group, LLC
Miami, Florida, United States
Gonzalez MD & Aswad MD Health Services
Miami, Florida, United States
Miami Jewish Health
Miami, Florida, United States
Blue Medical Research Inc.
Miami, Florida, United States
Brainstorm Research
Miami, Florida, United States
Brain Matters Research (Kane Center)
Stuart, Florida, United States
Conquest Research
Winter Park, Florida, United States
Emory University Goizueta Alzheimer's Disease Research Center(GADRC)
Atlanta, Georgia, United States
Sandhill Research, LLC d/b/a Accel Research Sites
Decatur, Georgia, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Southern Illinois University
Springfield, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
MedVadis Research
Waltham, Massachusetts, United States
University of Michigan, Ann Arbor
Ann Arbor, Michigan, United States
Rutgers, Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Albany Medical College
Albany, New York, United States
Dent Neurologic Institute
Amherst, New York, United States
Integrative Clinical Trials
Brooklyn, New York, United States
Weill Cornell Medical College
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Nathan Kline Institute for Psychiatric Research
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
AMC Research LLC, dba Flourish Research
Matthews, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
Geisinger Memory and Cognition Center
Wilkes-Barre, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, United States
KCA Neurology
Tennessee City, Tennessee, United States
University of North Texas Health Science Center
Fort Worth, Texas, United States
Froedtert and Medical College of Wisconsin
Milwaukee, Wisconsin, United States