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Study Closed for Enrollment

A Randomized, Double-Blind Placebo-Controlled Trial of Valproate to Attenuate the Progression of Alzheimer's Disease

Project Director

Pierre Tariot, M.D.

Background and Significance

This study represents a novel clinical trial strategy designed to assess both prospective "prophylactic" therapy for psychopathology in Alzheimer's Disease (AD) and also to assess an approach that may alter several aspects of the pathophysiology of AD, thereby perhaps resulting in the alteration of clinical progression of illness. Interpretation of these results will be supported by the study of relevant biomarkers and imaging data.

Primary Objective

To determine whether chronic valproate therapy delays the emergence of agitation and/or psychosis in outpatients with probable Alzheimer's disease (AD) who have not experienced agitation and psychosis in their illness.

Secondary Objectives

The chief secondary aim is to determine whether chronic valproate therapy for up to two years delays the progression of cognitive and functional measures of illness.

Study Design

This is a randomized, double-blind, placebo-controlled, parallel design study of valproate at a target dose of approximately 10-12 mg/kg per day in outpatients with probable AD, treated for 24 months followed by a two month washout.

Study Size

Approximately 300 participants were enrolled from 25-35 centers throughout the U.S.

How Subjects Were Selected

Men and women with a diagnosis of probable AD age 55 years or older, weighing at least 40 kg, residing in the community at baseline. Additionally, patients had a Mini Mental State Exam (MMSE) score of 12-20 inclusive who had not experienced agitation or psychosis since the onset of their illness and who did not require treatment with psychotropic medications with the exception of antidepressants used only for the treatment of depressive symptoms and limited use of sedatives for sleep.