Status:
COMPLETED
Benfotiamine in Alzheimer's Disease: A Pilot Study
Lead Sponsor:
Burke Medical Research Institute
Collaborating Sponsors:
Burke Rehabilitation Hospital
Columbia University
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
General Investigational Plan Study Objectives The goal of this proposal is to determine whether enhancing brain glucose utilization minimizes cognitive decline in patients with Amnestic Mild Cognitiv...
Detailed Description
Study Design This study will be conducted at the Burke Rehabilitation Hospital under an IRB protocol. Wplan to accrue a total of 76 male and/or female patients (\> 65 years) with a diagnosis of AMCI/...
Eligibility Criteria
Inclusion
- 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 \> or equal to 21
- CDR score \> or equal to 0.5 and \< or equal to1
- 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
- If they are on AD medications they must be stable on AD medications for at least three months prior to baseline
- Subjects ore willing/able to provide informed consent.
Exclusion
- 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)
- A1C less than or equal to 8
- Current diagnosis of cancer/active treatments
Key Trial Info
Start Date :
February 15 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2020
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT02292238
Start Date
February 15 2015
End Date
September 8 2020
Last Update
June 28 2022
Active Locations (1)
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1
Burke
White Plains, New York, United States, 10605