RecruitingPhase 2NCT06223360

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

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)

Sponsor

Alzheimer's Disease Cooperative Study (ADCS)

Enrollment

406 participants

Start Date

Mar 28, 2024

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease

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.

Eligibility

Min Age: 50 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether benfotiamine (a form of vitamin B1) can slow the progression of early Alzheimer's disease in people who are beginning to show symptoms but still have mild impairment. **You may be eligible if...** - You are between 50 and 89 years old - You have mild cognitive impairment or mild dementia due to Alzheimer's disease, confirmed by testing and biomarkers - Your memory test scores fall in a specific range (MMSE 20–30, MoCA below 26) - You have a study partner (friend or family member) who sees you at least 3–4 times a week - You speak English or Spanish fluently - You are ambulatory (able to walk, with or without a device) **You may NOT be eligible if...** - You have another serious neurological condition (stroke, Parkinson's, Lewy body dementia, etc.) - You have uncontrolled diabetes (HbA1c of 8 or higher) - You have an active seizure disorder - You have a history of alcoholism or drug abuse in the last 5 years - You have taken benfotiamine in the past 3 months - You cannot have an MRI scan - You have received a monoclonal antibody for brain amyloid within 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLow Dose Benfotiamine

300mg benfotiamine capsules (BID, twice a day)

DRUGHigh Dose Benfotiamine

600mg benfotiamine capsules (BID, twice a day)

DRUGPlacebo

Placebo capsules to mimic benfotiamine capsules (BID, twice a day)

Locations(47)

St. Joseph's Hospital and Medical Center/Barrow Neurological Institute

Phoenix, Arizona, United States

Perseverance Research Center, LLC

Scottsdale, Arizona, United States

Banner Sun Health Research Institute

Sun City, Arizona, United States

The Neuron Clinic

Chula Vista, California, United States

University of California, Irvine

Irvine, California, United States

Pacific Research Network

Lemon Grove, California, United States

University of Southern California

Los Angeles, California, United States

Cedars Sinai, Los Angeles

Los Angeles, California, United States

Syrentis Clinical Research

Santa Ana, California, United States

JEM Research Institute

Atlantis, Florida, United States

Brain Matters Research

Delray Beach, Florida, United States

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, United States

CCM Clinical Research Group, LLC

Miami, Florida, United States

Gonzalez MD & Aswad MD Health Services

Miami, Florida, United States

Miami Jewish Health

Miami, Florida, United States

Blue Medical Research Inc.

Miami, Florida, United States

Brainstorm Research

Miami, Florida, United States

Brain Matters Research (Kane Center)

Stuart, Florida, United States

Conquest Research

Winter Park, Florida, United States

Emory University Goizueta Alzheimer's Disease Research Center(GADRC)

Atlanta, Georgia, United States

Sandhill Research, LLC d/b/a Accel Research Sites

Decatur, Georgia, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Southern Illinois University

Springfield, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

University of Kentucky

Lexington, Kentucky, United States

MedVadis Research

Waltham, Massachusetts, United States

University of Michigan, Ann Arbor

Ann Arbor, Michigan, United States

Rutgers, Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Albany Medical College

Albany, New York, United States

Dent Neurologic Institute

Amherst, New York, United States

Integrative Clinical Trials

Brooklyn, New York, United States

Weill Cornell Medical College

New York, New York, United States

Mount Sinai School of Medicine

New York, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

Nathan Kline Institute for Psychiatric Research

New York, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

AMC Research LLC, dba Flourish Research

Matthews, North Carolina, United States

Case Western Reserve University

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Oregon Health & Science University (OHSU)

Portland, Oregon, United States

Geisinger Memory and Cognition Center

Wilkes-Barre, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Ralph H. Johnson VA Health Care System

Charleston, South Carolina, United States

KCA Neurology

Tennessee City, Tennessee, United States

University of North Texas Health Science Center

Fort Worth, Texas, United States

Froedtert and Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06223360

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

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(47)

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