Start:
November 2014
End:
September 2020
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?
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
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?
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