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Not recruiting
Phase 2

Benfotiamine

Sponsor:

Alzheimer's Disease Cooperative Study (ADCS)

Code:

NCT06223360

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Low Dose Benfotiamine

High Dose Benfotiamine

Placebo

Study Details

Brief summary:

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

Alzheimer Disease

Study ID

NCT06223360

Start date

Mar 28, 2024

Status verified date

Feb, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

406 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low Dose Benfotiamine

Participants will take 300mg benfotiamine capsules twice a day (BID; once in the morning and once in the evening).

experimental: High Dose Benfotiamine

Participants will take 600mg benfotiamine capsules twice a day (BID; once in the morning and once in the evening).

placebo comparator: 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.

Interventions

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)

Primary outcome measure

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

Central Contacts and Locations

More Information

Sponsor

Alzheimer's Disease Cooperative Study (ADCS)

Last update posted

Jun 4, 2026

Last verified

Feb, 2026

Keywords

  • Mild Cognitive Impairment
  • Mild Alzheimer's Disease
  • Early Alzheimer's disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by Alzheimer's Disease Cooperative Study (ADCS) on 2026-06-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.