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RECRUITING
NCT06223360
PHASE2

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

Sponsor: Alzheimer's Disease Cooperative Study (ADCS)

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

50 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

406

Start Date

2024-03-28

Completion Date

2027-12-01

Last Updated

2026-02-23

Healthy Volunteers

No

Interventions

DRUG

Low Dose Benfotiamine

300mg benfotiamine capsules (BID, twice a day)

DRUG

High Dose Benfotiamine

600mg benfotiamine capsules (BID, twice a day)

DRUG

Placebo

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