At a glance
ClinicalIndex Comparison Record- ✓Probable Alzheimer's disease diagnosed by NINDS-ADRDA criteria
- ✓Age 55–89 years
- ✓MMSE score 12–20 at screening and baseline
- ✓Community residence; assisted living allowed if not intensive dementia care or secure units
- ✕Non-Alzheimer dementia
- ✕Females of child-bearing potential
- ✕Long-term care nursing facility residence at baseline
- ✕History of agitation or psychosis requiring active psychotropic medication since illness onset
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled Trial of Valproate to Attenuate the Progression of Alzheimer's Disease (AD)
In Brief
A Phase 3 clinical trial evaluating Valproate and Placebo for Alzheimer Disease. Completed, enrolled 313 participants across 46 sites.
Detailed Summary
The purpose of this trial is to demonstrate whether 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. A secondary aim is to determine whether valproate therapy delays the progression of cognitive and functional measures of the illness. This trial will also assess the tolerability and safety of low-dose, long-term valproate therapy. Valproate, an anticonvulsant drug, was selected because of its possible symptomatic efficacy for agitation in AD, known safety profile in numerous clinical populations, and in view of recent data supporting its neuroprotective potential in AD.
Study Details
Timeline
Interventions
250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout