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Benfotiamine in Alzheimer's Disease

Start: November 2014

End: May 1, 2021

Enrollment: 76

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?

Minimum Age: 65 Years

Maximum Age: N/A

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.

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

New York
Burke
White Plains, 10605

Who Sponsors This Study?

Lead: Burke Medical Research Institute

Source: ClinicalTrials.gov ID: NCT02292238