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Evaluating Benfotiamine for Early Alzheimer's Disease

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)

Phase 2 Interventional Alzheimer's Disease Cooperative Study (ADCS) · NCT06223360

This study is testing if a supplement called benfotiamine can safely help people with early Alzheimer's disease improve their thinking and overall performance.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment406 (estimated)
Ages50 Years to 89 Years
SexAll
SponsorAlzheimer's Disease Cooperative Study (ADCS) Academic / other
Locations47 sites (Phoenix, Arizona and 46 other locations)
Trial IDNCT06223360 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of benfotiamine in patients with early Alzheimer's disease. It is a randomized, double-blind, placebo-controlled trial involving 406 participants over 18 months. The study consists of two phases: Phase 2A focuses on determining the highest safe dose of benfotiamine, while Phase 2B evaluates its efficacy on cognitive function and global performance. Participants will be monitored for tolerability and safety throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 to 89 with mild cognitive impairment or mild dementia due to Alzheimer's disease.

Not a fit: Patients with advanced Alzheimer's disease or those not meeting the cognitive assessment criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could slow the progression of symptoms in patients with early Alzheimer's disease.

How similar studies have performed: Other studies have explored similar interventions, but the specific use of benfotiamine in this context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* 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).

Where this trial is running

Phoenix, Arizona and 46 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alzheimer DiseaseMild Cognitive ImpairmentMild Alzheimer's DiseaseEarly Alzheimer's disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.