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Vitamin E and memantine in Alzheimer's disease: clinical trial methods and baseline data.


ABSTRACT: Alzheimer's disease (AD) has been associated with both oxidative stress and excessive glutamate activity. A clinical trial was designed to compare the effectiveness of (i) alpha-tocopherol, a vitamin E antioxidant; (ii) memantine (Namenda), an N-methyl-D-aspartate antagonist; (iii) their combination; and (iv) placebo in delaying clinical progression in AD.The Veterans Affairs Cooperative Studies Program initiated a multicenter, randomized, double-blind, placebo-controlled trial in August 2007, with enrollment through March 2012 and follow-up continuing through September 2012. Participants with mild-to-moderate AD who were taking an acetylcholinesterase inhibitor were assigned randomly to 2000 IU/day of alpha-tocopherol, 20 mg/day memantine, 2000 IU/day alpha-tocopherol plus 20 mg/day memantine, or placebo. The primary outcome for the study is the Alzheimer's Disease Cooperative Study/Activities of Daily Living Inventory. Secondary outcome measures include the Mini-Mental State Examination; the Alzheimer's Disease Assessment Scale, cognitive portion; the Dependence Scale; the Neuropsychiatric Inventory; and the Caregiver Activity Survey. Patient follow-up ranged from 6 months to 4 years.A total of 613 participants were randomized. The majority of the patients were male (97%) and white (86%), with a mean age of 79 years. The mean Alzheimer's Disease Cooperative Study/Activities of Daily Living Inventory score at entry was 57 and the mean Mini-Mental State Examination score at entry was 21.This large multicenter trial will address the unanswered question of the long-term safety and effectiveness of alpha-tocopherol, memantine, and their combination in patients with mild-to-moderate AD taking an acetylcholinesterase inhibitor. The results are expected in early 2013.

SUBMITTER: Dysken MW 

PROVIDER: S-EPMC4128187 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

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Vitamin E and memantine in Alzheimer's disease: clinical trial methods and baseline data.

Dysken Maurice W MW   Guarino Peter D PD   Vertrees Julia E JE   Asthana Sanjay S   Sano Mary M   Llorente Maria M   Pallaki Muralidhar M   Love Susan S   Schellenberg Gerard D GD   McCarten J Riley JR   Malphurs Julie J   Prieto Susana S   Chen Peijun P   Loreck David J DJ   Carney Sara S   Trapp George G   Bakshi Rajbir S RS   Mintzer Jacobo E JE   Heidebrink Judith L JL   Vidal-Cardona Ana A   Arroyo Lillian M LM   Cruz Angel R AR   Kowall Neil W NW   Chopra Mohit P MP   Craft Suzanne S   Thielke Stephen S   Turvey Carolyn L CL   Woodman Catherine C   Monnell Kimberly A KA   Gordon Kimberly K   Tomaska Julie J   Vatassery Govind G  

Alzheimer's & dementia : the journal of the Alzheimer's Association 20130411 1


<h4>Background</h4>Alzheimer's disease (AD) has been associated with both oxidative stress and excessive glutamate activity. A clinical trial was designed to compare the effectiveness of (i) alpha-tocopherol, a vitamin E antioxidant; (ii) memantine (Namenda), an N-methyl-D-aspartate antagonist; (iii) their combination; and (iv) placebo in delaying clinical progression in AD.<h4>Methods</h4>The Veterans Affairs Cooperative Studies Program initiated a multicenter, randomized, double-blind, placebo  ...[more]

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