Format

Send to:

Choose Destination
See comment in PubMed Commons below
Alzheimers Dement. 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.

Author information

  • 1VA Minneapolis Health Care System, Minneapolis, MN, USA. Electronic address: maurice.dysken@va.gov.
  • 2Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System, West Haven, CT, USA.
  • 3VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM, USA.
  • 4William S. Middleton Memorial Veterans Hospital, Madison, WI, USA.
  • 5Bronx Veterans Medical Research Center, New York, NY, USA.
  • 6VAMC, Washington, DC, USA.
  • 7Louis Stokes Cleveland VAMC, Cleveland, OH, USA.
  • 8VA Minneapolis Health Care System, Minneapolis, MN, USA.
  • 9University of Pennsylvania School of Medicine, Philadelphia, PA, USA.
  • 10VA Miami Healthcare System, Miami, FL, USA.
  • 11VA Maryland Healthcare System, University of Maryland Medical School, Department of Psychiatry, Baltimore, MD, USA.
  • 12VA Maryland Healthcare System, Baltimore, MD, USA.
  • 13VA North Texas Healthcare System, Dallas, TX, USA.
  • 14Ralph H. Johnson VAMC, Medical University of South Carolina, Charleston, SC, USA.
  • 15VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.
  • 16VA Caribbean Healthcare System, San Juan, PR.
  • 17Bay Pines VA Healthcare System, Bay Pines, FL, USA.
  • 18VA Boston Healthcare System, Boston, MA, USA.
  • 19VA Puget Sound Healthcare System, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA.
  • 20Iowa City VAMC, University of Iowa, Iowa City, IA, USA.
  • 21W.G. (Bill) Hefner VAMC, Salisbury, NC, USA.

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.

Published by Elsevier Inc.

KEYWORDS:

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

PMID:
23583234
[PubMed - indexed for MEDLINE]
PMCID:
PMC4128187
Free PMC Article
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Elsevier Science Icon for PubMed Central
    Loading ...
    Write to the Help Desk