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

Key Inclusion Criteria:

• Aged 50 to 89 (inclusive) at screening

• Mild Cognitive Impairment (MCI) due to AD or Mild dementia due to AD according toworkgroups of the Diagnostic Guidelines of the National Institute on Aging andAlzheimer's Association (NIA-AA)

• Mini-Mental State Examination (MMSE) score 20-30 inclusive at screening-. MontrealCognitive Assessment score (MoCA) < 26 at screening

• Clinical Dementia Rating (CDR) global score of 0.5 or 1 with memory score of greateror 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 3months 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 inperson or remotely, and can assist in compliance with study procedures.

• Female participants must be post-menopausal for at least one year or surgicallysterile(bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) for atleast 6 months prior to screening.

• Fluent in English or Spanish to ensure compliance with cognitive testing and studyvisit procedures.

• Ambulatory, or able to walk with an assistive device.

• Provision of informed consent from the participant (or the participant's legallyauthorized representative (LAR) if unable to provide consent) and the study partner.

Key Exclusion Criteria:

• Significant neurological disorder other than AD (e.g. hypoxia, stroke, traumaticbrain 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 SupranuclearPalsy), AIDS (Acquired Immunodeficiency Syndrome), or NPH (normal pressurehydrocephalus).

• Meeting Diagnostic Criteria for Possible AD according to workgroups of theDiagnostic Guidelines of the NIA-AA.

• A current diagnosis of uncontrolled Type I or Type II diabetes mellitus, as definedby Hemoglobin A1C (Hb A1C ≥ 8).

• A current active, uncontrolled seizure disorder.

• Diagnosis of cancer, except for those participants who have undergone potentiallycurative 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 havingtaken 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 investigationaltrial is defined as the date of the last dose of an investigational agent.

• Initiation of a monoclonal antibody treatment targeting brain amyloid within 6months prior to the baseline visit.

• A disability that may prevent the patient from completing all study requirementse.g.,blindness, deafness, severe language difficulty).