613
Participants
Start Date
August 31, 2007
Primary Completion Date
September 30, 2012
Study Completion Date
October 31, 2012
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."
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.
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."
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.
Placebo
Matching placebos for dl-alpha-tocopherol and memantine.
VA Maryland Health Care System, Baltimore, Baltimore
Salisbury VAMC, Salisbury
VA Medical Center, Miami, Miami
VA Medical Center, Bay Pines, Bay Pines
VA Medical Center, Cleveland, Cleveland
VA Ann Arbor Healthcare System, Ann Arbor
Wlliam S. Middleton Memorial Veterans Hospital, Madison, Madison
VA Medical Center, Minneapolis, Minneapolis
VA North Texas Health Care System, Dallas, Dallas
VA Puget Sound Health Care System, Seattle, Seattle
VA Medical Center, Iowa City, Iowa City
VA Medical Center, Jamaica Plain Campus, Boston
Ralph H Johnson VA Medical Center, Charleston, Charleston
VA Medical Center, San Juan, San Juan
Collaborators (1)
Forest Laboratories
INDUSTRY
DSM Nutritional Products, Inc.
INDUSTRY
US Department of Veterans Affairs
FED