Evaluating Benfotiamine for Early Alzheimer's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• St. Joseph's Hospital and Medical Center/Barrow Neurological Institute
  Phoenix, Arizona, United States Recruiting
• Perseverance Research Center, LLC
  Scottsdale, Arizona, United States Recruiting
• Banner Sun Health Research Institute
  Sun City, Arizona, United States Recruiting
• The Neuron Clinic
  Chula Vista, California, United States Recruiting
• University of California, Irvine
  Irvine, California, United States Recruiting
• University of Southern California
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Howard Feldman, MDCM — Alzheimer's Disease Cooperative Study (ADCS)
• Study coordinator: ADCS Recruitment Team
• Email: adcs-recruitment@health.ucsd.edu
• Phone: 877-807-1290

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.