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 June 12, 2025
Recruiting
Keywords
ClinConnect Summary
The BenfoTeam trial is studying a medication called Benfotiamine to see if it can help slow down the symptoms of early Alzheimer's disease. This study is specifically looking at people aged 50 to 89 who have mild cognitive impairment or mild dementia due to Alzheimer's. To participate, candidates need to have certain test scores that show they have early signs of Alzheimer's and must have a study partner who can help them throughout the trial.
If you or someone you know is interested in joining this study, it's important to know that participants will need to attend regular visits, either in person or online, and will be closely monitored for the safety and effectiveness of the treatment. The trial is currently recruiting participants, so this could be a chance to contribute to research that may help others with Alzheimer's in the future.
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Springfield, Illinois, United States
New York, New York, United States
Columbus, Ohio, United States
Cleveland, Ohio, United States
Iowa City, Iowa, United States
Providence, Rhode Island, United States
Chicago, Illinois, 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
New York, New York, United States
Fort Worth, Texas, United States
Atlantis, Florida, United States
Portland, Oregon, United States
Sun City, Arizona, United States
Ann Arbor, Michigan, United States
Phoenix, Arizona, United States
Lexington, Kentucky, United States
Santa Ana, California, United States
Brooklyn, New York, United States
Miami, Florida, United States
Waltham, Massachusetts, United States
Miami, Florida, United States
Charleston, South Carolina, United States
Stuart, Florida, United States
New York, New York, United States
Los Angeles, California, United States
Tennessee, Tennessee, United States
Lemon Grove, California, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Patients applied
Trial Officials
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported