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Randomized Controlled Trial
. 2014 Jan;10(1):36-44.
doi: 10.1016/j.jalz.2013.01.014. Epub 2013 Apr 11.

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

Maurice W Dysken  1 , Peter D Guarino  2 , Julia E Vertrees  3 , Sanjay Asthana  4 , Mary Sano  5 , Maria Llorente  6 , Muralidhar Pallaki  7 , Susan Love  8 , Gerard D Schellenberg  9 , J Riley McCarten  8 , Julie Malphurs  10 , Susana Prieto  10 , Peijun Chen  7 , David J Loreck  11 , Sara Carney  12 , George Trapp  13 , Rajbir S Bakshi  13 , Jacobo E Mintzer  14 , Judith L Heidebrink  15 , Ana Vidal-Cardona  16 , Lillian M Arroyo  16 , Angel R Cruz  17 , Neil W Kowall  18 , Mohit P Chopra  18 , Suzanne Craft  19 , Stephen Thielke  19 , Carolyn L Turvey  20 , Catherine Woodman  20 , Kimberly A Monnell  21 , Kimberly Gordon  21 , Julie Tomaska  8 , Govind Vatassery  8
Affiliations
Randomized Controlled Trial

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

Maurice W Dysken et al. Alzheimers Dement. 2014 Jan.

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Keywords: Alpha-tocopherol; Alzheimer's disease; Cholinesterase inhibitors; Memantine; Randomized trials; Vitamin E.

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Figures

Figure 1
Figure 1
Flow of Participants in the Study
See this image and copyright information in PMC

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