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

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).