Actively Recruiting
A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)
Led by Alzheimer's Disease Cooperative Study (ADCS) · Updated on 2026-02-23
406
Participants Needed
47
Research Sites
191 weeks
Total Duration
On this page
Sponsors
A
Alzheimer's Disease Cooperative Study (ADCS)
Lead Sponsor
B
Burke Medical Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 89 years inclusive at screening
- Diagnosis of mild cognitive impairment or mild dementia due to Alzheimer's disease
- Mini-Mental State Examination (MMSE) score between 20 and 30 inclusive
- Montreal Cognitive Assessment (MoCA) score less than 26 at screening
- Clinical Dementia Rating (CDR) global score of 0.5 or 1 with a memory score of at least 0.5
- Positive blood test for Alzheimer's disease biomarkers
- Stable dose of FDA-approved acetylcholinesterase inhibitors or memantine for at least 3 months before screening if treated
- Have a study partner who interacts with participant more than 3-4 times per week and can attend visits
- Female participants must be post-menopausal for at least one year or surgically sterile for at least 6 months
- Fluent in English or Spanish
- Able to walk independently or with an assistive device
- Provide informed consent themselves or via legally authorized representative and study partner
You will not qualify if you...
- Significant neurological disorders other than Alzheimer's disease such as stroke, hypoxia, or traumatic brain injury
- Other neurodegenerative diseases or dementias besides Alzheimer's, including Parkinson's, Huntington's, Lewy Body dementia, Creutzfeldt-Jakob disease, Progressive Supranuclear Palsy, AIDS, or normal pressure hydrocephalus
- Meeting diagnostic criteria for possible Alzheimer's disease according to NIA-AA guidelines
- Uncontrolled type 1 or type 2 diabetes (HbA1C ≥ 8)
- Active, uncontrolled seizure disorder
- Diagnosis of cancer unless treated with no recurrence for more than 5 years
- History of alcoholism or substance abuse within the past 5 years
- Previous exposure to Benfotiamine within the past 3 months
- Contraindications to MRI
- Participation in another investigational drug trial with study drug use within 4 weeks before baseline unless placebo
- Started monoclonal antibody treatment targeting brain amyloid within 6 months before baseline
- Disabilities that prevent completing study requirements such as blindness, deafness, or severe language difficulty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 47 locations
1
St. Joseph's Hospital and Medical Center/Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
Perseverance Research Center, LLC
Scottsdale, Arizona, United States, 85253
Actively Recruiting
3
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
Actively Recruiting
4
The Neuron Clinic
Chula Vista, California, United States, 91910
Actively Recruiting
5
University of California, Irvine
Irvine, California, United States, 92697
Actively Recruiting
6
Pacific Research Network
Lemon Grove, California, United States, 91945
Terminated
7
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
8
Cedars Sinai, Los Angeles
Los Angeles, California, United States, 90048
Actively Recruiting
9
Syrentis Clinical Research
Santa Ana, California, United States, 92705
Actively Recruiting
10
JEM Research Institute
Atlantis, Florida, United States, 33462
Actively Recruiting
11
Brain Matters Research
Delray Beach, Florida, United States, 33445
Actively Recruiting
12
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States, 33912
Actively Recruiting
13
CCM Clinical Research Group, LLC
Miami, Florida, United States, 33133
Actively Recruiting
14
Gonzalez MD & Aswad MD Health Services
Miami, Florida, United States, 33135
Actively Recruiting
15
Miami Jewish Health
Miami, Florida, United States, 33137
Actively Recruiting
16
Blue Medical Research Inc.
Miami, Florida, United States, 33144
Actively Recruiting
17
Brainstorm Research
Miami, Florida, United States, 33176
Actively Recruiting
18
Brain Matters Research (Kane Center)
Stuart, Florida, United States, 34997
Actively Recruiting
19
Conquest Research
Winter Park, Florida, United States, 32789
Actively Recruiting
20
Emory University Goizueta Alzheimer's Disease Research Center(GADRC)
Atlanta, Georgia, United States, 30329
Actively Recruiting
21
Sandhill Research, LLC d/b/a Accel Research Sites
Decatur, Georgia, United States, 30030
Actively Recruiting
22
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
23
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
24
Southern Illinois University
Springfield, Illinois, United States, 62702
Actively Recruiting
25
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
26
University of Kentucky
Lexington, Kentucky, United States, 40504
Actively Recruiting
27
MedVadis Research
Waltham, Massachusetts, United States, 02451
Actively Recruiting
28
University of Michigan, Ann Arbor
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
29
Rutgers, Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
30
Albany Medical College
Albany, New York, United States, 12208
Actively Recruiting
31
Dent Neurologic Institute
Amherst, New York, United States, 14226
Actively Recruiting
32
Integrative Clinical Trials
Brooklyn, New York, United States, 11229
Actively Recruiting
33
Weill Cornell Medical College
New York, New York, United States, 10021
Actively Recruiting
34
Mount Sinai School of Medicine
New York, New York, United States, 10029
Actively Recruiting
35
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
36
Nathan Kline Institute for Psychiatric Research
New York, New York, United States, 10962
Actively Recruiting
37
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
38
AMC Research LLC, dba Flourish Research
Matthews, North Carolina, United States, 28105
Actively Recruiting
39
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Actively Recruiting
40
Ohio State University
Columbus, Ohio, United States, 43221
Actively Recruiting
41
Oregon Health & Science University (OHSU)
Portland, Oregon, United States, 97239
Actively Recruiting
42
Geisinger Memory and Cognition Center
Wilkes-Barre, Pennsylvania, United States, 18711
Actively Recruiting
43
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
44
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, United States, 29401
Actively Recruiting
45
KCA Neurology
Tennessee City, Tennessee, United States, 37067
Actively Recruiting
46
University of North Texas Health Science Center
Fort Worth, Texas, United States, 76107
Actively Recruiting
47
Froedtert and Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
A
ADCS Recruitment Team
CONTACT
B
Bryce Truver, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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