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Benfotiamine in Alzheimer's Disease

Active, not recruiting

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.

Minimum Age Maximum Age Gender Healthy Volunteers
65 Years N/A Both No
November 2014
November 2019
76

  • 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

  • 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

This pilot study will determine if increasing brain thiamine levels by taking benfotiamine will increase the brain's use of glucose and slow cognitive decline in people with MCI or mild Alzheimer's disease. Benfotiamine, a synthetic version of thiamine (vitamin B1), is thought to act by enhancing brain glucose utilization.

Participants must have elevated levels of the protein amyloid in the brain, a hallmark of Alzheimer's. They will be randomly assigned to either take the study drug (300 mg/morning and 300 mg/evening) or a placebo for 1 year. They will undergo PET imaging to detect brain gluclose metabolism, as well as laboratory tests and tests of memory and other aspects of cognition. Each participant will make a total of six visits to the study site.

Investigators will attempt to identify the population that most benefits from benfotiamine. They will also compare changes in glucose utilization between the benfotiamine and placebo groups in the whole brain and in various brain regions, including the hippocampus, prefrontal regions, and entorhinal cortex.

Name City State Zip Status Primary Contact
Burke
White Plains New York 10605

Burke Medical Research Institute

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

Name Role Affiliation
Gary E. Gibson, PhD Principal Investigator Burke Medical Research Institute
Barry D. Jordan, MD, MPH Principal Investigator Burke Rehabilitation Hospital

Name Phone Email
Rosanna Cirio 914-597-2476 rcirio@burke.org

NCT02292238

Benfotiamine in Alzheimer's Disease: A Pilot Study