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Could a Vitamin-Like pill slow Alzheimer's? new trial seeks answers

NCT ID NCT06223360

Disease control Sponsor: Weill Medical College of Cornell University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 4 times

Summary

This study tests whether benfotiamine, a form of vitamin B1, can safely slow memory and thinking decline in people with early Alzheimer's. About 406 adults aged 50-89 with mild symptoms will take the drug or a placebo for up to 72 weeks. Researchers will measure changes in cognition and daily function, and monitor side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

406 people

The number who actually took part.

Started

Mar 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 89 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease

Contacts and locations

Locations

  • AMC Research LLC, dba Flourish Research

    Matthews, North Carolina, 28105, United States

  • Albany Medical College

    Albany, New York, 12208, United States

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351, United States

  • Blue Medical Research Inc.

    Miami, Florida, 33144, United States

  • Brain Matters Research

    Delray Beach, Florida, 33445, United States

  • Brain Matters Research (Kane Center)

    Stuart, Florida, 34997, United States

  • Brainstorm Research

    Miami, Florida, 33176, United States

  • CCM Clinical Research Group, LLC

    Miami, Florida, 33133, United States

  • Case Western Reserve University

    Cleveland, Ohio, 44106, United States

  • Cedars Sinai, Los Angeles

    Los Angeles, California, 90048, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Conquest Research

    Winter Park, Florida, 32789, United States

  • Dent Neurologic Institute

    Amherst, New York, 14226, United States

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

    Atlanta, Georgia, 30329, United States

  • Froedtert and Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Geisinger Memory and Cognition Center

    Wilkes-Barre, Pennsylvania, 18711, United States

  • Gonzalez MD & Aswad MD Health Services

    Miami, Florida, 33135, United States

  • Integrative Clinical Trials

    Brooklyn, New York, 11229, United States

  • JEM Research Institute

    Atlantis, Florida, 33462, United States

  • KCA Neurology

    Tennessee City, Tennessee, 37067, United States

  • MedVadis Research

    Waltham, Massachusetts, 02451, United States

  • Miami Jewish Health

    Miami, Florida, 33137, United States

  • Mount Sinai School of Medicine

    New York, New York, 10029, United States

  • Nathan Kline Institute for Psychiatric Research

    New York, New York, 10962, United States

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912, United States

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611, United States

  • Ohio State University

    Columbus, Ohio, 43221, United States

  • Oregon Health & Science University (OHSU)

    Portland, Oregon, 97239, United States

  • Pacific Research Network

    Lemon Grove, California, 91945, United States

  • Perseverance Research Center, LLC

    Scottsdale, Arizona, 85253, United States

  • Ralph H. Johnson VA Health Care System

    Charleston, South Carolina, 29401, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Rutgers, Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901, United States

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

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

    Decatur, Georgia, 30030, United States

  • Southern Illinois University

    Springfield, Illinois, 62702, United States

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

    Phoenix, Arizona, 85013, United States

  • Syrentis Clinical Research

    Santa Ana, California, 92705, United States

  • The Neuron Clinic

    Chula Vista, California, 91910, United States

  • University of California, Irvine

    Irvine, California, 92697, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Kentucky

    Lexington, Kentucky, 40504, United States

  • University of Michigan, Ann Arbor

    Ann Arbor, Michigan, 48109, United States

  • University of North Texas Health Science Center

    Fort Worth, Texas, 76107, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • Weill Cornell Medical College

    New York, New York, 10021, United States

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