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Vitamin E and memantine in Alzheimer's disease: clinical trial methods and baseline data.
Alzheimers Dement 2014; 10(1):36-44AD

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.

Authors+Show Affiliations

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

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

23583234

Citation

Dysken, Maurice W., et al. "Vitamin E and Memantine in Alzheimer's Disease: Clinical Trial Methods and Baseline Data." Alzheimer's & Dementia : the Journal of the Alzheimer's Association, vol. 10, no. 1, 2014, pp. 36-44.
Dysken MW, Guarino PD, Vertrees JE, et al. Vitamin E and memantine in Alzheimer's disease: clinical trial methods and baseline data. Alzheimers Dement. 2014;10(1):36-44.
Dysken, M. W., Guarino, P. D., Vertrees, J. E., Asthana, S., Sano, M., Llorente, M., ... Vatassery, G. (2014). Vitamin E and memantine in Alzheimer's disease: clinical trial methods and baseline data. Alzheimer's & Dementia : the Journal of the Alzheimer's Association, 10(1), pp. 36-44. doi:10.1016/j.jalz.2013.01.014.
Dysken MW, et al. Vitamin E and Memantine in Alzheimer's Disease: Clinical Trial Methods and Baseline Data. Alzheimers Dement. 2014;10(1):36-44. PubMed PMID: 23583234.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Vitamin E and memantine in Alzheimer's disease: clinical trial methods and baseline data. AU - Dysken,Maurice W, AU - Guarino,Peter D, AU - Vertrees,Julia E, AU - Asthana,Sanjay, AU - Sano,Mary, AU - Llorente,Maria, AU - Pallaki,Muralidhar, AU - Love,Susan, AU - Schellenberg,Gerard D, AU - McCarten,J Riley, AU - Malphurs,Julie, AU - Prieto,Susana, AU - Chen,Peijun, AU - Loreck,David J, AU - Carney,Sara, AU - Trapp,George, AU - Bakshi,Rajbir S, AU - Mintzer,Jacobo E, AU - Heidebrink,Judith L, AU - Vidal-Cardona,Ana, AU - Arroyo,Lillian M, AU - Cruz,Angel R, AU - Kowall,Neil W, AU - Chopra,Mohit P, AU - Craft,Suzanne, AU - Thielke,Stephen, AU - Turvey,Carolyn L, AU - Woodman,Catherine, AU - Monnell,Kimberly A, AU - Gordon,Kimberly, AU - Tomaska,Julie, AU - Vatassery,Govind, Y1 - 2013/04/11/ PY - 2012/07/04/received PY - 2013/01/06/revised PY - 2013/01/21/accepted PY - 2013/4/16/entrez PY - 2013/4/16/pubmed PY - 2014/8/12/medline KW - Alpha-tocopherol KW - Alzheimer's disease KW - Cholinesterase inhibitors KW - Memantine KW - Randomized trials KW - Vitamin E SP - 36 EP - 44 JF - Alzheimer's & dementia : the journal of the Alzheimer's Association JO - Alzheimers Dement VL - 10 IS - 1 N2 - 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. SN - 1552-5279 UR - https://www.unboundmedicine.com/medline/citation/23583234/Vitamin_E_and_memantine_in_Alzheimer's_disease:_clinical_trial_methods_and_baseline_data_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1552-5260(13)00046-0 DB - PRIME DP - Unbound Medicine ER -