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Benfotiamine in Alzheimer's Disease: A Pilot Study (Benfotiamine)

CLINICAL TRIAL: 
In-Progress / Currently Recruiting Participants
November 10, 2014 to November 1, 2019
Trial Identifier: 
NCT02292238
Published Clinical Trial: 
clinicaltrials.gov

Burke is currently conducting a clinical trial to evaluate whether increasing brain glucose utilization can slow cognitive decline in patients with Amnestic Mild Cognitive Impairment or mild Alzheimer’s disease dementia.

Thiamine (vitamin B1) is closely linked to glucose metabolism, which is important to maintain memory and cognition. Many thiamine dependent processes are diminished in Alzheimer’s disease and reduced glucose utilization is one of the early symptoms of the development of Alzheimer’s disease. The goal of this trial is to determine if increasing brain thiamine availability with the new investigational drug benfotiamine will minimize the decline in glucose utilization and slow the cognitive decline associated with Alzheimer’s disease.

Individuals who are at least 60 years old and with a diagnosis of Amnestic Cognitive Impairment or Alzheimer’s disease may be eligible for participation. During this study we will give you a complete neurological exam, conduct tests of memory, learning and other cognitive functions, draw blood for laboratory measures, and use imaging to examine the presence of amyloid (plaques) in your brain and also the amount of glucose that your brain is using.

Study participation will be over a 12 month period and will include follow-up visits to our clinic every 3 months. There are no costs associated with participation in this study.

Eligibility

Age Range: 
60 Years to 95 Years
Gender: 
Both (Male and Female)
Healthy Volunteers: 
No
Inclusion Criteria: 
  • 60 years of age or older
  • Clinical diagnosis of AMCI by the Peterson criteria or probable AD dementia according to the National Institute of Neurological Disorders and stroke and the Alzheimer's Disease related Disorders Association (NINCDS/ADRDA)
  • MMSE score >21
  • CDR score >0.5 and >1
  • Cornell Scale for Depression in Dementia(CSDD) score <10.
  • Ambulatory or ambulatory with aide
  • Have a caregiver willing to accompany the patient to each visit, accept responsibility for supervising treatment and provided input to clinical outcome assessments
  • Reside at home
  • Speak English
  • Amyloid positive PET-scan
Exclusion Criteria: 
  • Patients with significant neurological disorder other than AD including hypoxia, stroke, traumatic brain injury
  • A current psychiatric disorder according the DSM-IV diagnosis of major depression unless successfully treated on a stable dose of an antidepressant for at least 4 weeks and continues on stable dose throughout the study
  • Any other DSM-IV Axis l diagnosis including other primary neurodegenerative dementia schizophrenia or bipolar depression
  • A current diagnosis of uncontrolled diabetes mellitus (glucose values > 200 mg/ml).
  • Patients with uncontrolled diabetes will be excluded because high glucose will alter the FDG-PET studies. The clinic that does PET (Columbia University Medical Center) excludes patients if glucose values exceed 200 mg/ml.
  • A current diagnosis of active, uncontrolled seizure disorder
  • A current diagnosis of probable or possible vascular dementia according to NINDS-AIREN
  • An investigational drug during the previous 4 weeks
  • A current diagnosis of severe unstable cardiovascular disease
  • A current diagnosis of acute severe, or unstable asthmatic condition (e.g., severe chronic obstructive pulmonary disease (COPD)
  • A current diagnosis of cardiac, renal or hepatic disease
  • History of alcoholism, current or within past 5 years
  • A disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, severe language difficulty)

Sponsor

National Institute on Aging (NIA), Alzheimer Drug Discovery Foundation, Burke Rehabilitation Hospital

Collaborators

National Institute on Aging (NIA), Alzheimer’s Drug Discovery Foundation, Burke Rehabilitation Hospital, Columbia University

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Study Locations

Burke Rehabilitation Hospital
785 Mamaroneck Avenue
White Plains, NY 10605

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