VA Cooperative Studies Program (CSP)

Investigator Access

What's Available

Check with the study contact and publications for information on a public dataset, data archive, data enclave, or website where data might be available.

Available Documentation

Dates Data are Available

Access Criteria

Study Characteristics

Objectives

To determine whether alpha-tocopherol, memantine (Namenda), or the combination will significantly delay clinical progression in mild-to-moderately demented patients with Alzheimer's disease compared with placebo.

Era of Service

All

Population

Patients within the VA health care system (97% male) diagnosed with possible or probable Alzheimer's disease of mild-to-moderate severity.

Study Design

Double-blind, placebo-controlled, parallel-group, randomized clinical trial

Intervention

• Experimental arm 1: 2,000 IU per day of dl-alpha-tocopherol plus placebo for memantine
• Experimental arm 2: 20 mg per day of memantine plus placebo for dl-alpha-tocopherol
• Experimental arm 3: Combination of 2,000 IU per day of dl-alpha-tocopherol and 20 mg per day of memantine
• Placebo Comparator arm 4: Matching placebos for dl-alpha-tocopherol and memantine

Time Period

August 2007 – September 2012

Setting

National

N

613 participants

Response Rate

91.8%

Recruitment Method

• Participants were recruited from 14 VA Medical Centers between August 2007 and March 2012
• 706 potential participants were initially screened by medical record review, 668 of those who appeared to be eligible were approached for consent, and 613 were randomized

Compensation

Unconfirmed

Data Collected

Primary outcome measures

• Alzheimer's disease cooperative study/activities of daily living (ADCS/ADL) inventory change from baseline
• Mini-mental state examination change from baseline
• Alzheimer's disease assessment scale - cognitive (ADAS-cog) change from baseline
• Neuropsychiatric inventory change from baseline
• Caregiver activity survey change from baseline

Secondary outcome measure: Dependence scale: time-to-event analysis (increase of one dependence level)

Additional outcome measure: All-cause mortality

Data Collection Methods

• Questionnaires and assessments at in-person (hospital or participant’s home) or phone-based study visits
• Medical records
• Physical exams
• Laboratory reports

Funding Sources

• VA Cooperative Studies Program (CSP)
• Forest Laboratories – Forest Research Institute
• DSM – DSM Nutritional Products 

Investigators

Principal Investigator: Maurice W. Dysken, MD

Study Chair: Maurice W. Dysken, MD

Contact

Elizabeth Jobes, Elizabeth.Jobes@va.gov

Selected Publications

Dysken MW, Sano M, Asthana S, Vertrees JE, Pallaki M, Llorente M, Love S, Schellenberg GD, McCarten JR, Malphurs J, Prieto S, Chen P, Loreck DJ, Trapp G, Bakshi RS, Mintzer JE, Heidebrink JL, Vidal-Cardona A, Arroyo LM, Cruz AR, Zachariah S, Kowall NW, Chopra MP, Craft S, Thielke S, Turvey CL, Woodman C, Monnell KA, Gordon K, Tomaska J, Segal Y, Peduzzi PN, Guarino PD. Effect of vitamin E and memantine on functional decline in Alzheimer disease: the TEAM-AD VA cooperative randomized trial. JAMA. 2014 Jan 1;311(1):33-44.


Dysken MW, Guarino PD, Vertrees JE, Asthana S, Sano M, Llorente M, Pallaki M, Love S, Schellenberg GD, McCarten JR, Malphurs J, Prieto S, Chen P, Loreck DJ, Carney S, Trapp G, Bakshi RS, Mintzer JE, Heidebrink JL, Vidal-Cardona A, Arroyo LM, Cruz AR, Kowall NW, Chopra MP, Craft S, Thielke S, Turvey CL, Woodman C, Monnell KA, Gordon K, Tomaska J, Vatassery G. Vitamin E and memantine in Alzheimer's disease: clinical trial methods and baseline data. Alzheimer's Dement. 2014 Jan;10(1):36-44.

More Information

Study ClinicalTrials.gov site

ClinicalTrials.gov Identifier: NCT00235716