Search / Trial NCT06223360

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

Launched by ALZHEIMER'S DISEASE COOPERATIVE STUDY (ADCS) · Jan 16, 2024

Trial Information

Current as of October 08, 2024

Recruiting

Keywords

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

Description

This is a randomized, double-blind, placebo-controlled 18-month clinical trial of benfotiamine in early AD. This trial will include a seamless phase 2A-2B design with a randomized total sample of 406 participants. Participants who are randomized but drop out prior to study drug exposure will be replaced. 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 m...

Gender

ALL

Eligibility 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).

About Alzheimer's Disease Cooperative Study (Adcs)

The Alzheimer's Disease Cooperative Study (ADCS) is a prominent research organization dedicated to advancing the understanding and treatment of Alzheimer's disease and related dementias. Established to facilitate collaborative clinical trials and innovative research, ADCS focuses on the development and evaluation of novel therapeutic interventions and diagnostic tools. By bringing together leading academic institutions, healthcare professionals, and industry partners, ADCS aims to improve the quality of care for individuals affected by Alzheimer's disease through rigorous scientific inquiry and the promotion of evidence-based practices.

Locations

Los Angeles, California, United States

Springfield, Illinois, United States

Columbus, Ohio, United States

Iowa City, Iowa, United States

Providence, Rhode Island, United States

Irvine, California, United States

Syracuse, New York, United States

Albany, New York, United States

Amherst, New York, United States

Delray Beach, Florida, United States

Fort Myers, Florida, United States

Fort Worth, Texas, United States

Ann Arbor, Michigan, United States

Lexington, Kentucky, United States

Santa Ana, California, United States

Brooklyn, New York, United States

Stuart, Florida, United States

New York, New York, United States

Los Angeles, California, United States

Tennessee, Tennessee, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0