Status:
COMPLETED
A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease
Lead Sponsor:
US Department of Veterans Affairs
Collaborating Sponsors:
Forest Laboratories
DSM Nutritional Products, Inc.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether alpha-tocopherol, memantine (Namenda), or the combination will significantly delay clinical progression in mild to moderately demented patients with A...
Detailed Description
Abstract: Alzheimer's disease (AD), a neurodegenerative disorder resulting in cognitive loss, behavioral problems, and functional decline, is characterized by well-established and well-known neuropath...
Eligibility Criteria
Inclusion
- Diagnoses of possible or probable Alzheimer's disease (NINCDS-ADRDA)
- Presence of a caregiver (friend or relative) who can assume responsibility for medication compliance, can accompany the patient to all visits, and rate patient's condition
- Written informed consent from both the patient (or surrogate) and caregiver
- An MMSE score between 12 and 26 inclusive
- Administration of a maintenance dosage of donepezil (5-10mg/d), rivastigmine (6-12mg/d) or rivastigmine (Exelon) patch (4.6 mg or 9.5 mg), galantamine or galantamine ER (16-24mg/d) for a minimum of 4 weeks prior to randomization
- Agreement not to take vitamin E supplements and/or memantine outside of the study (daily multivitamin is permitted containing up to 100 IU alpha-tocopherol)
Exclusion
- A non-Alzheimer primary dementia (e.g., vascular dementia, Lewy body dementia, fronto-temporal dementia, vitamin B-12 deficiency, hypothyroidism)
- Current major depression, delirium, alcohol or psychoactive substance abuse or dependency, schizophrenia, or delusional disorder as defined by DSM-IV
- Presence of any uncontrolled systemic illness that would interfere with participation in the study or a life expectancy of less than one year
- Pregnant or intention to become pregnant
- Enrollment in another interventional clinical trial
- Current prescription with more than one AChE inhibitor
- Current prescription for warfarin
- Use of vitamin E supplements in the past 2 weeks
- Use of memantine in the past 4 weeks or known intolerance
- Estimated creatinine clearance less than 5ml/min (Cockcroft-Gault formula)
- Use of amantadine in the past 2 weeks
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
613 Patients enrolled
Trial Details
Trial ID
NCT00235716
Start Date
August 1 2007
End Date
October 1 2012
Last Update
July 23 2014
Active Locations (14)
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1
VA Medical Center, Bay Pines
Bay Pines, Florida, United States, 33708
2
VA Medical Center, Miami
Miami, Florida, United States, 33125
3
VA Medical Center, Iowa City
Iowa City, Iowa, United States, 52246-2208
4
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201