Benfotiamine in Alzheimer's Disease

What Is This Study About?

This clinical trial will determine if benfotiamine, a dietary supplement, can minimize cognitive decline in older adults with amnestic mild cognitive impairment (MCI) or mild Alzheimer's disease.

Do I Qualify To Participate in This Study?

Must have:

• Clinical diagnosis of amnestic MCI or probable Alzheimer's disease (Mini Mental State Examination score of >21 and Clinical Dementia Rating score >0.5 and >1)
• Cornell Scale for Depression in Dementia score of <10
• Ambulatory or ambulatory with assistance
• Caregiver willing to accompany the participant to each visit, accept responsibility for supervising treatment, and provide input to clinical outcome assessments
• Lives at home
• English speaking
• Amyloid-positive PET scan

Must NOT have:

• Significant neurological disorder other than Alzheimer's, including hypoxia, stroke, or traumatic brain injury
• Current psychiatric disorder according to DSM-IV (treatment with stable dose of antidepressant for at least 4 weeks allowed)
• Any other DSM-IV Axis l diagnosis, including other primary neurodegenerative dementia, schizophrenia, or bipolar depression
• Uncontrolled diabetes mellitus (glucose values >200 mg/ml)
• Active, uncontrolled seizure disorder
• Probable or possible vascular dementia
• Use of an investigational drug during the previous 4 weeks
• Severe, unstable cardiovascular disease
• Acute, severe, or unstable asthmatic condition, such as severe chronic obstructive pulmonary disease
• Current diagnosis of cardiac, renal, or hepatic disease
• History of alcoholism (current or within past 5 years)
• Disability that may prevent the participant from completing all study requirements, such as blindness, deafness, or severe language difficulty

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Where Is This Study Located?

Who Sponsors This Study?

Lead: Burke Medical Research Institute

Collaborator Sponsor

• Burke Rehabilitation Hospital
• Columbia University
• National Institute on Aging (NIA)
• Alzheimer’s Drug Discovery Foundation
• Montefiore-Albert Einstein College of Medicine

Source: ClinicalTrials.gov ID: NCT02292238