RECRUITING

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

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Conditions

Alzheimer DiseaseMild Cognitive ImpairmentMild Alzheimer's DiseaseEarly Alzheimer's disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2024-03-22
Study Completion:2027-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06223360

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 50 to 89 (inclusive) at screening
  2. * 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)
  3. * Mini-Mental State Examination (MMSE) score 20-30 inclusive at screening-. Montreal Cognitive Assessment score (MoCA) \< 26 at screening
  4. * Clinical Dementia Rating (CDR) global score of 0.5 or 1 with memory score of greater or equal to 0.5 at screening
  5. * Positive plasma AD biomarker signature
  6. * 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.
  7. * 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.
  8. * 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.
  9. * Fluent in English or Spanish to ensure compliance with cognitive testing and study visit procedures.
  10. * Ambulatory, or able to walk with an assistive device.
  11. * Provision of informed consent from the participant (or the participant's legally authorized representative (LAR) if unable to provide consent) and the study partner.
  1. * Significant neurological disorder other than AD (e.g. hypoxia, stroke, traumatic brain injury
  2. * 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).
  3. * Meeting Diagnostic Criteria for Possible AD according to workgroups of the Diagnostic Guidelines of the NIA-AA.
  4. * A current diagnosis of uncontrolled Type I or Type II diabetes mellitus, as defined by Hemoglobin A1C (Hb A1C ≥ 8).
  5. * A current active, uncontrolled seizure disorder.
  6. * Diagnosis of cancer, except for those participants who have undergone potentially curative therapy with no evidence of recurrence for \> 5 years.
  7. * History of alcoholism or substance abuse, current or within past 5 years.
  8. * Previous exposure to Benfotiamine within past 3 months.
  9. * Contraindication to MRI.
  10. * 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.
  11. * Initiation of a monoclonal antibody treatment targeting brain amyloid within 6 months prior to the baseline visit.
  12. * A disability that may prevent the patient from completing all study requirements e.g.,blindness, deafness, severe language difficulty).

Contacts and Locations

Study Contact

ADCS Recruitment Team
CONTACT
877-807-1290
adcs-recruitment@health.ucsd.edu
Bryce Truver, MS
CONTACT
619-818-3769
btruver@health.ucsd.edu

Principal Investigator

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

Study Locations (Sites)

University of California, Irvine
Irvine, California, 92697
United States
University of Southern California
Los Angeles, California, 90033
United States
Cedars Sinai, Los Angeles
Los Angeles, California, 90048
United States
Syrentis Clinical Research
Santa Ana, California, 92705
United States
Brain Matters Research
Delray Beach, Florida, 33445
United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912
United States
Brain Matters Research (Kane Center)
Stuart, Florida, 34997
United States
Southern Illinois University
Springfield, Illinois, 62702
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
Albany Medical College
Albany, New York, 12208
United States
Dent Neurologic Institute
Amherst, New York, 14226
United States
Integrative Clinical Trials
Brooklyn, New York, 11229
United States
Nathan Kline Institute for Psychiatric Research
New York, New York, 10962
United States
SUNY Upstate Medical University
Syracuse, New York, 13210
United States
Ohio State University
Columbus, Ohio, 43221
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
KCA Neurology
Tennessee, Tennessee, 37067
United States
University of North Texas Health Science Center
Fort Worth, Texas, 76107
United States

Collaborators and Investigators

Sponsor: Alzheimer's Disease Cooperative Study (ADCS)

  • 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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-22
Study Completion Date2027-02-01

Study Record Updates

Study Start Date2024-03-22
Study Completion Date2027-02-01

Terms related to this study

Keywords Provided by Researchers

  • Mild Cognitive Impairment
  • Mild Alzheimer's Disease
  • Early Alzheimer's disease

Additional Relevant MeSH Terms

  • Alzheimer Disease