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NCT06223360

A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)

Active, Not Recruiting
PHASE2Ages 50–89InterventionalTreatment
Alzheimer's Disease Cooperative Study (ADCS)
~406 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Low Dose BenfotiamineHigh Dose BenfotiaminePlacebo

At a glance

Recruiting sites
0 of 47 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 2A: The rate of tolerability events (TEs).
Measured over Up to 72 weeks
+2 more outcomes measured

Conditions

Alzheimer Disease

Explore related trials

Alzheimer's DiseaseMild cognitive disorderplasma AD biomarker signature

Where it's being run

47 sites across 20 states
Florida10
New York8
California6
Arizona3
Illinois3
Georgia2
Ohio2
Iowa1

Study leadership

  • Howard Feldman, MDCM · PRINCIPAL_INVESTIGATOR · Alzheimer's Disease Cooperative Study (ADCS)
  • Gary E. Gibson, PhD · STUDY_DIRECTOR · Burke Neurological Institute
  • Jose A. Luchsinger, MD MPH · STUDY_DIRECTOR · Columbia University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Aged 50 to 89 (inclusive) at screening
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

Significant neurological disorder other than AD (e.g. hypoxia, stroke, traumatic brain injury
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).

What this trial measures

  • Phase 2A: The rate of tolerability events (TEs).Up to 72 weeks

    The primary safety outcome in phase 2A is the rate of tolerability events (TEs) compared between active arms (benfotiamine) and placebo arms, at each dose. A TE is counted when either a participant discontinues study drug due to intolerability or experiences a moderate or severe adverse event (AE) that is determined to be possibly, probably or definitely related to study drug.

  • Phase 2B: The primary cognitive endpoint is the within-participant change from baseline to 72 weeks compared between active arms (benfotiamine) and placebo on the Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog13).72 weeks

    ADAS-Cog13 is a structured psychometric scale that evaluates memory (immediate and delayed word recall; immediate word recognition), receptive and expressive language, orientation, ideational praxis (preparing a letter for mailing), constructional praxis (copying figures), and attention (number cancellation). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions also are obtained. ADAS-Cog13 total score has a range of 0-85; with higher scores indicating greater impairment.

  • Phase 2B: The primary functional endpoint is the within-participant change from baseline to 72 weeks compared between active arm (benfotiamine) and placebo on the Clinical Dementia Rating - Sum of Boxes (CDR-SB).72 weeks

    CDR-SB is a composite rating of cognition and everyday function which incorporates both informant input and direct assessment of performance. It assesses through semi-structured interview three cognitive domains (memory, orientation, and judgement/problem solving) and three everyday functional domains (community affairs, home and hobbies, personal care). Level of impairment in each of the six domains is rated from none (score=0) to severe (score=3). The six domain scores are then summed to create the CDR-SB. Range 0-18; higher scores indicate greater impairment.