A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)
NCT ID: NCT06223360
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
406 participants
INTERVENTIONAL
2024-03-28
2027-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Low Dose Benfotiamine
Participants will take 300mg benfotiamine capsules twice a day (BID; once in the morning and once in the evening).
Low Dose Benfotiamine
300mg benfotiamine capsules (BID, twice a day)
High Dose Benfotiamine
Participants will take 600mg benfotiamine capsules twice a day (BID; once in the morning and once in the evening).
High Dose Benfotiamine
600mg benfotiamine capsules (BID, twice a day)
Placebo
Participants will take placebo capsules twice a day (BID; once in the morning and once in the evening). In the placebo group, capsules will be filled with inactive microcrystalline cellulose. The other capsule components, shape and color are identical between benfotiamine and placebo arms.
Placebo
Placebo capsules to mimic benfotiamine capsules (BID, twice a day)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* Mild Cognitive Impairment (MCI) due to AD or Mild dementia due to AD according to workgroups of the Diagnostic Guidelines of the National Institute on Aging and Alzheimer's Association (NIA-AA)
* Mini-Mental State Examination (MMSE) score 20-30 inclusive at screening-. Montreal Cognitive Assessment score (MoCA) \< 26 at screening
* Clinical Dementia Rating (CDR) global score of 0.5 or 1 with memory score of greater or equal to 0.5 at screening
* Positive plasma AD biomarker signature
* Participants who are treated with FDA-approved acetylcholinesterase inhibitors (AchEI)and/or memantine will have to be on a stable dosage regimen for at least 3 months prior to screening.
* Participants must have a study partner who has frequent interaction with them (approximately \>3-4 times per week), will be available for all clinic visits in person or remotely, and can assist in compliance with study procedures.
* Female participants must be post-menopausal for at least one year or surgically sterile(bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 6 months prior to screening.
* Fluent in English or Spanish to ensure compliance with cognitive testing and study visit procedures.
* Ambulatory, or able to walk with an assistive device.
* Provision of informed consent from the participant (or the participant's legally authorized representative (LAR) if unable to provide consent) and the study partner.
Exclusion Criteria
* Significant neurodegenerative diseases, other than AD, and causes of dementias, Parkinson's disease and Huntington's disease, vascular dementia, CJD (Creutzfeldt-Jakob disease), LBD (Lewy Body dementia), PSP (Progressive Supranuclear Palsy), AIDS (Acquired Immunodeficiency Syndrome), or NPH (normal pressure hydrocephalus).
* Meeting Diagnostic Criteria for Possible AD according to workgroups of the Diagnostic Guidelines of the NIA-AA.
* A current diagnosis of uncontrolled Type I or Type II diabetes mellitus, as defined by Hemoglobin A1C (Hb A1C ≥ 8).
* A current active, uncontrolled seizure disorder.
* Diagnosis of cancer, except for those participants who have undergone potentially curative therapy with no evidence of recurrence for \> 5 years.
* History of alcoholism or substance abuse, current or within past 5 years.
* Previous exposure to Benfotiamine within past 3 months.
* Contraindication to MRI.
* Participation in another clinical trial for an investigational agent and having taken at least one dose of study drug, unless confirmed as having been on placebo, within 4 weeks prior to the baseline visit. The end of a previous investigational trial is defined as the date of the last dose of an investigational agent.
* Initiation of a monoclonal antibody treatment targeting brain amyloid within 6 months prior to the baseline visit.
* A disability that may prevent the patient from completing all study requirements e.g.,blindness, deafness, severe language difficulty).
50 Years
89 Years
ALL
No
Sponsors
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Burke Medical Research Institute
OTHER
National Institute on Aging (NIA)
NIH
Alzheimer's Disease Cooperative Study (ADCS)
OTHER
Responsible Party
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Principal Investigators
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Howard Feldman, MDCM
Role: PRINCIPAL_INVESTIGATOR
Alzheimer's Disease Cooperative Study (ADCS)
Gary E. Gibson, PhD
Role: STUDY_DIRECTOR
Burke Neurological Institute
Jose A. Luchsinger, MD MPH
Role: STUDY_DIRECTOR
Columbia University
Locations
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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
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
Countries
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Central Contacts
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References
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Feldman HH, Luchsinger JA, Leger GC, Taylor C, Jacobs DM, Salmon DP, Edland SD, Messer K, Revta C, Flowers SA, Jones KS, Koulman A, Yarasheski KE, Verghese PB, Venkatesh V, Zetterberg H, Durant J, Lupo JL, Gibson GE; ADCS BenfoTeam Study Group. Protocol for 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). PLoS One. 2024 May 29;19(5):e0302998. doi: 10.1371/journal.pone.0302998. eCollection 2024.
Other Identifiers
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ADC-061-BENFO
Identifier Type: -
Identifier Source: org_study_id
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