A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

613

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

September 30, 2012

Study Completion Date

October 31, 2012

Conditions
Alzheimer's Disease
Interventions
DRUG

dl-alpha-tocopherol

"Alpha-tocopherol will be given as an oral dose of 1000 IU twice a day (morning and evening). The form of vitamin E that will be used in this study will be hard gel capsules of dl-alpha-tocopheryl acetate (synthetic) vitamin E."

DRUG

Memantine

A moderate-affinity NMDA antagonist. Memantine will be titrated over four weeks to a maintenance dose of 10 mg twice a day. During week 1 patients will take one 5-mg memantine tablet in the morning. During week 2 patients will take one 5-mg memantine tablet in the morning and one in the evening. During week 3 patients will take two 5-mg memantine tablets in the morning and one 5-mg tablet in the evening. Beginning with week 4, participants will take four 5-mg tablets daily, two in the morning and two in the evening.

DRUG

dl-alpha-tocopherol

"Alpha-tocopherol will be given as an oral dose of 1000 IU twice a day (morning and evening). The form of vitamin E that will be used in this study will be hard gel capsules of dl-alpha-tocopheryl acetate (synthetic) vitamin E."

DRUG

Memantine

A moderate-affinity NMDA antagonist. Memantine will be titrated over four weeks to a maintenance dose of 10 mg twice a day. During week 1 patients will take one 5-mg memantine tablet in the morning. During week 2 patients will take one 5-mg memantine tablet in the morning and one in the evening. During week 3 patients will take two 5-mg memantine tablets in the morning and one 5-mg tablet in the evening. Beginning with week 4, participants will take four 5-mg tablets daily, two in the morning and two in the evening.

DRUG

Placebo

Matching placebos for dl-alpha-tocopherol and memantine.

Trial Locations (14)

21201

VA Maryland Health Care System, Baltimore, Baltimore

28144

Salisbury VAMC, Salisbury

33125

VA Medical Center, Miami, Miami

33708

VA Medical Center, Bay Pines, Bay Pines

44106

VA Medical Center, Cleveland, Cleveland

48113

VA Ann Arbor Healthcare System, Ann Arbor

53705

Wlliam S. Middleton Memorial Veterans Hospital, Madison, Madison

55417

VA Medical Center, Minneapolis, Minneapolis

75216

VA North Texas Health Care System, Dallas, Dallas

98108

VA Puget Sound Health Care System, Seattle, Seattle

52246-2208

VA Medical Center, Iowa City, Iowa City

02130

VA Medical Center, Jamaica Plain Campus, Boston

29401-5799

Ralph H Johnson VA Medical Center, Charleston, Charleston

00921

VA Medical Center, San Juan, San Juan

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Forest Laboratories

INDUSTRY

collaborator

DSM Nutritional Products, Inc.

INDUSTRY

lead

US Department of Veterans Affairs

FED