Alzheimer's Disease Cooperative Study (ADCS)
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.
Alzheimer Disease
Low Dose Benfotiamine
High Dose Benfotiamine
Placebo
PHASE2
This is a randomized, double-blind, placebo-controlled 18-month clinical trial of benfotiamine in early AD. This trial will include a seamless phase 2A-2B design with a randomized total sample of 406 participants. Participants who are randomized but drop out prior to study drug exposure will be replaced. Phase 2A of the trial will randomize approximately 150 participants total, in a 1:1:1 to treatment with 1200 mg/day benfotiamine, 600 mg/day benfotiamine or placebo. The primary objective of phase 2A is to determine the highest safe and well tolerated dose of benfotiamine (600 mg or 1200 mg), as evaluated by the rate of tolerability events (TEs), for advancement to long-term 72 week exposure. The highest tolerated dose of benfotiamine will be carried forward from phase 2A to phase 2B. At the start of phase 2B, all participants enrolled in the two phase 2A active dose arms will receive a new supply of benfotiamine at the selected phase 2B dose. All phase 2A participants will be included in the phase 2 intent-to-treat efficacy population, as assigned to active or placebo treatment. The primary objective of phase 2B is to assess efficacy of benfotiamine on global function and cognition over 72 weeks. In phase 2B, a composite cognitive and functional measure as well as PD biomarkers will be used to evaluate efficacy during the extended treatment period. Phase 2B will also evaluate longer-term safety and tolerability of benfotiamine treatment over 72 weeks.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 406 participants |
Masking : | TRIPLE |
Primary Purpose : | TREATMENT |
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) |
Actual Study Start Date : | 2024-03-22 |
Estimated Primary Completion Date : | 2027-02-01 |
Estimated Study Completion Date : | 2027-02-01 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 50 Years to 89 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
University of California, Irvine
Irvine, California, United States, 92697
RECRUITING
University of Southern California
Los Angeles, California, United States, 90033
RECRUITING
Cedars Sinai, Los Angeles
Los Angeles, California, United States, 90048
RECRUITING
Syrentis Clinical Research
Santa Anna, California, United States, 92705
RECRUITING
Brain Matters Research
Delray Beach, florida, United States, 33445
RECRUITING
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, florida, United States, 33912
RECRUITING
Brain Matters Research (Kane Center)
Stuart, florida, United States, 34997
RECRUITING
Southern Illinois University
Springfield, Illinois, United States, 62702
RECRUITING
University of Iowa
Iowa City, Iowa, United States, 52242
RECRUITING
University of Kentucky
Lexington, Kentucky, United States, 40504
RECRUITING
University of Michigan, Ann Arbor
Ann Arbor, road cancer, United States, 48109
RECRUITING
Albany Medical College
Albany, New York, United States, 12208
RECRUITING
Dent Neurologic Institute
Amherst, New York, United States, 14226
RECRUITING
Integrative Clinical Trials
Brooklyn, New York, United States, 11229
RECRUITING
Nathan Kline Institute for Psychiatric Research
New York, New York, United States, 10962
RECRUITING
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
RECRUITING
Ohio State University
Columbus, Ohio, United States, 43221
RECRUITING
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
RECRUITING
KCA Neurology
Tennessee, Tennessee, United States, 37067
RECRUITING
University of North Texas Health Science Center
Fort Worth, Texas, United States, 76107