Start: November 2014
End: September 8, 2020
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?
- 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.
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?
Lead: Burke Medical Research Institute
Burke Rehabilitation Hospital
National Institute on Aging (NIA)
Alzheimer’s Drug Discovery Foundation
Montefiore-Albert Einstein College of Medicine
Source: ClinicalTrials.gov ID: NCT02292238