RECRUITINGPhase 2INTERVENTIONAL
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)
About This Trial
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.
Who May Be Eligible (Plain English)
Key Who May Qualify:
- 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 willing to sign a consent form from the participant (or the participant's legally authorized representative (LAR) if unable to provide consent) and the study partner.
Key Who Should NOT Join This Trial:
- 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 weakened immune system Syndrome), or NPH (normal pressure hydrocephalus).
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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).
Treatments Being Tested
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 (20)
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