Journal article
Vitamin E and memantine in Alzheimer's disease: Clinical trial methods and baseline data
Alzheimer's & dementia, Vol.10(1), pp.36-44
01/2014
DOI: 10.1016/j.jalz.2013.01.014
PMCID: PMC4128187
PMID: 23583234
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.
Details
- Title: Subtitle
- Vitamin E and memantine in Alzheimer's disease: Clinical trial methods and baseline data
- Creators
- Maurice W Dysken - VA Minneapolis Health Care System, Minneapolis, MN, USAPeter D Guarino - Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System, West Haven, CT, USAJulia E Vertrees - VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM, USASanjay Asthana - William S. Middleton Memorial Veterans Hospital, Madison, WI, USAMary Sano - Bronx Veterans Medical Research Center, New York, NY, USAMaria Llorente - VAMC, Washington, DC, USAMuralidhar Pallaki - Louis Stokes Cleveland VAMC, Cleveland, OH, USASusan Love - VA Minneapolis Health Care System, Minneapolis, MN, USAGerard D Schellenberg - University of Pennsylvania School of Medicine, Philadelphia, PA, USAJ. Riley McCarten - VA Minneapolis Health Care System, Minneapolis, MN, USAJulie Malphurs - VA Miami Healthcare System, Miami, FL, USASusana Prieto - VA Miami Healthcare System, Miami, FL, USAPeijun Chen - Louis Stokes Cleveland VAMC, Cleveland, OH, USADavid J Loreck - VA Maryland Healthcare System, University of Maryland Medical School, Department of Psychiatry, Baltimore, MD, USASara Carney - VA Maryland Healthcare System, Baltimore, MD, USAGeorge Trapp - VA North Texas Healthcare System, Dallas, TX, USARajbir S Bakshi - VA North Texas Healthcare System, Dallas, TX, USAJacobo E Mintzer - Ralph H. Johnson VAMC, Medical University of South Carolina, Charleston, SC, USAJudith L Heidebrink - VA Ann Arbor Healthcare System, Ann Arbor, MI, USAAna Vidal-Cardona - VA Caribbean Healthcare System, San Juan, PRLillian M Arroyo - VA Caribbean Healthcare System, San Juan, PRAngel R Cruz - Bay Pines VA Healthcare System, Bay Pines, FL, USANeil W Kowall - VA Boston Healthcare System, Boston, MA, USAMohit P Chopra - VA Boston Healthcare System, Boston, MA, USASuzanne Craft - VA Puget Sound Healthcare System, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USAStephen Thielke - VA Puget Sound Healthcare System, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USACarolyn L Turvey - Iowa City VAMC, University of Iowa, Iowa City, IA, USACatherine Woodman - Iowa City VAMC, University of Iowa, Iowa City, IA, USAKimberly A Monnell - W.G. (Bill) Hefner VAMC, Salisbury, NC, USAKimberly Gordon - W.G. (Bill) Hefner VAMC, Salisbury, NC, USAJulie Tomaska - VA Minneapolis Health Care System, Minneapolis, MN, USAGovind Vatassery - VA Minneapolis Health Care System, Minneapolis, MN, USA
- Resource Type
- Journal article
- Publication Details
- Alzheimer's & dementia, Vol.10(1), pp.36-44
- DOI
- 10.1016/j.jalz.2013.01.014
- PMID
- 23583234
- PMCID
- PMC4128187
- NLM abbreviation
- Alzheimers Dement
- ISSN
- 1552-5260
- eISSN
- 1552-5279
- Publisher
- Elsevier Inc
- Grant note
- name: Department of Veterans Affairs Cooperative Studies Program; name: DSM Nutritional Products, Inc.; name: Arista Industries, Inc.
- Language
- English
- Date published
- 01/2014
- Academic Unit
- Psychiatry; Epidemiology; Family and Community Medicine
- Record Identifier
- 9984003433502771
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