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

Summary

The purpose of this study is 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 to placebo.

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.

Sponsors & Collaborators

• Forest Laboratories

  collaborator INDUSTRY

• DSM Nutritional Products, Inc.

  collaborator INDUSTRY

• US Department of Veterans Affairs

  lead FED

Principal Investigators

• Maurice Dysken · Minneapolis Veterans Affairs Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-08-31

Primary Completion

2012-09-30

Completion

2012-10-31

Countries

• United States
• Puerto Rico

Study Locations