Trials Today

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

Purpose

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.

Condition

Alzheimer Disease

Eligibility

Eligible Ages: Between 50 Years and 89 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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.

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).

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Triple (Participant, Care Provider, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Low Dose Benfotiamine	Participants will take 300mg benfotiamine capsules twice a day (BID; once in the morning and once in the evening).	Drug: Low Dose Benfotiamine 300mg benfotiamine capsules (BID, twice a day)
Experimental High Dose Benfotiamine	Participants will take 600mg benfotiamine capsules twice a day (BID; once in the morning and once in the evening).	Drug: High Dose Benfotiamine 600mg benfotiamine capsules (BID, twice a day)
Placebo Comparator Placebo	Participants will take placebo capsules twice a day (BID; once in the morning and once in the evening). In the placebo group, capsules will be filled with inactive microcrystalline cellulose. The other capsule components, shape and color are identical between benfotiamine and placebo arms.	Drug: Placebo Placebo capsules to mimic benfotiamine capsules (BID, twice a day)

Recruiting Locations

St. Joseph's Hospital and Medical Center/Barrow Neurological Institute
Phoenix 5308655, Arizona 5551752 85013

Perseverance Research Center, LLC
Scottsdale 5313457, Arizona 5551752 85253

Banner Sun Health Research Institute
Sun City 5316201, Arizona 5551752 85351

The Neuron Clinic
Chula Vista 5336899, California 5332921 91910

University of California, Irvine
Irvine 5359777, California 5332921 92697

University of Southern California
Los Angeles 5368361, California 5332921 90033

Cedars Sinai, Los Angeles
Los Angeles 5368361, California 5332921 90048

Syrentis Clinical Research
Santa Ana 5392900, California 5332921 92705

JEM Research Institute
Atlantis 4146372, Florida 4155751 33462

Brain Matters Research
Delray Beach 4153132, Florida 4155751 33445

Neuropsychiatric Research Center of Southwest Florida
Fort Myers 4155995, Florida 4155751 33912

CCM Clinical Research Group, LLC
Miami 4164138, Florida 4155751 33133

Gonzalez MD & Aswad MD Health Services
Miami 4164138, Florida 4155751 33135

Miami Jewish Health
Miami 4164138, Florida 4155751 33137

Blue Medical Research Inc.
Miami 4164138, Florida 4155751 33144

Brainstorm Research
Miami 4164138, Florida 4155751 33176

Brain Matters Research (Kane Center)
Stuart 4174201, Florida 4155751 34997

Conquest Research
Winter Park 4178560, Florida 4155751 32789

Emory University Goizueta Alzheimer's Disease Research Center(GADRC)
Atlanta 4180439, Georgia 4197000 30329

Sandhill Research, LLC d/b/a Accel Research Sites
Decatur 4191124, Georgia 4197000 30030

Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612

Southern Illinois University
Springfield 4250542, Illinois 4896861 62702

University of Iowa
Iowa City 4862034, Iowa 4862182 52242

University of Kentucky
Lexington 4297983, Kentucky 6254925 40504

MedVadis Research
Waltham 4954380, Massachusetts 6254926 02451

University of Michigan, Ann Arbor
Ann Arbor 4984247, Michigan 5001836 48109

Rutgers, Robert Wood Johnson Medical School
New Brunswick 5101717, New Jersey 5101760 08901

Albany Medical College
Albany 5106834, New York 5128638 12208

Dent Neurologic Institute
Amherst 5107129, New York 5128638 14226

Integrative Clinical Trials
Brooklyn 5110302, New York 5128638 11229

Weill Cornell Medical College
New York 5128581, New York 5128638 10021

Mount Sinai School of Medicine
New York 5128581, New York 5128638 10029

Columbia University Irving Medical Center
New York 5128581, New York 5128638 10032

Nathan Kline Institute for Psychiatric Research
New York 5128581, New York 5128638 10962

SUNY Upstate Medical University
Syracuse 5140405, New York 5128638 13210

AMC Research LLC, dba Flourish Research
Matthews 4478334, North Carolina 4482348 28105

Case Western Reserve University
Cleveland 5150529, Ohio 5165418 44106

Ohio State University
Columbus 4509177, Ohio 5165418 43221

Oregon Health & Science University (OHSU)
Portland 5746545, Oregon 5744337 97239

Geisinger Memory and Cognition Center
Wilkes-Barre 5219488, Pennsylvania 6254927 18711

Rhode Island Hospital
Providence 5224151, Rhode Island 5224323 02903

Ralph H. Johnson VA Health Care System
Charleston 4574324, South Carolina 4597040 29401

KCA Neurology
Tennessee City 4662109, Tennessee 4662168 37067

University of North Texas Health Science Center
Fort Worth 4691930, Texas 4736286 76107

Froedtert and Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226

More Details

NCT ID: NCT06223360
Status: Recruiting
Sponsor: Alzheimer's Disease Cooperative Study (ADCS)

Study Contact

ADCS Recruitment Team
877-807-1290
adcs-recruitment@health.ucsd.edu

Detailed 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 mg), as evaluated by the rate of tolerability events (TEs), for advancement to long-term 72 week exposure. The highest tolerated dose of benfotiamine will be carried forward from phase 2A to phase 2B. At the start of phase 2B, all participants enrolled in the two phase 2A active dose arms will receive a new supply of benfotiamine at the selected phase 2B dose. All phase 2A participants will be included in the phase 2 intent-to-treat efficacy population, as assigned to active or placebo treatment. The primary objective of phase 2B is to assess efficacy of benfotiamine on global function and cognition over 72 weeks. In phase 2B, a composite cognitive and functional measure as well as PD biomarkers will be used to evaluate efficacy during the extended treatment period. Phase 2B will also evaluate longer-term safety and tolerability of benfotiamine treatment over 72 weeks.