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

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.

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  • Authors+Show Affiliations

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    VA Minneapolis Health Care System, Minneapolis, MN, USA. Electronic address: maurice.dysken@va.gov.

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    Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System, West Haven, CT, USA.

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    VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM, USA.

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    William S. Middleton Memorial Veterans Hospital, Madison, WI, USA.

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    Bronx Veterans Medical Research Center, New York, NY, USA.

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    VAMC, Washington, DC, USA.

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    Louis Stokes Cleveland VAMC, Cleveland, OH, USA.

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    VA Minneapolis Health Care System, Minneapolis, MN, USA.

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    University of Pennsylvania School of Medicine, Philadelphia, PA, USA.

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    VA Minneapolis Health Care System, Minneapolis, MN, USA.

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    VA Miami Healthcare System, Miami, FL, USA.

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    VA Miami Healthcare System, Miami, FL, USA.

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    Louis Stokes Cleveland VAMC, Cleveland, OH, USA.

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    VA Maryland Healthcare System, University of Maryland Medical School, Department of Psychiatry, Baltimore, MD, USA.

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    VA Maryland Healthcare System, Baltimore, MD, USA.

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    VA North Texas Healthcare System, Dallas, TX, USA.

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    VA North Texas Healthcare System, Dallas, TX, USA.

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    Ralph H. Johnson VAMC, Medical University of South Carolina, Charleston, SC, USA.

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    VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.

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    VA Caribbean Healthcare System, San Juan, PR.

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    VA Caribbean Healthcare System, San Juan, PR.

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    Bay Pines VA Healthcare System, Bay Pines, FL, USA.

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    VA Boston Healthcare System, Boston, MA, USA.

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    VA Boston Healthcare System, Boston, MA, USA.

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    VA Puget Sound Healthcare System, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA.

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    VA Puget Sound Healthcare System, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA.

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    Iowa City VAMC, University of Iowa, Iowa City, IA, USA.

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    Iowa City VAMC, University of Iowa, Iowa City, IA, USA.

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    W.G. (Bill) Hefner VAMC, Salisbury, NC, USA.

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    W.G. (Bill) Hefner VAMC, Salisbury, NC, USA.

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    VA Minneapolis Health Care System, Minneapolis, MN, USA.

    VA Minneapolis Health Care System, Minneapolis, MN, USA.

    Source

    MeSH

    Aged
    Aged, 80 and over
    Alzheimer Disease
    Antioxidants
    Double-Blind Method
    Excitatory Amino Acid Antagonists
    Female
    Humans
    Longitudinal Studies
    Male
    Memantine
    Psychiatric Status Rating Scales
    Veterans
    Vitamin E

    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 -