Safety and Efficacy of Divalproex and Quetiapine in Elderly Alzheimer's Dementia Patients

Dementia Clinical Trial

Official title: An Open Label, Randomized, Flexible Dose, 6-week Clinical Trial of the Safety and Efficacy of Divalproex ER vs Quetiapine in the Treatment of Behavioral Symptoms in the Elderly With Moderate to Severe Alzheimer's Dementia

Status Withdrawn

Clinical Trial Summary

The primary aim is to determine whether Divalproex ER or one of the atypical antipsychotics is more effective improving dementia related behavioral symptoms in patients with dementia, and evaluate the impact of such improvements on other clinical domains, such as quality of life, functional status.

Clinical Trial Description

This clinical trial will be open label, flexible dose study of Divalproex ER vs Quetiapine for 6 weeks. Patients will be randomized to Divalproex ER vs Quetiapine outpatient / inpatient. The schedule of visits will include a screening, a baseline and 3 treatment visits / assessment. The End of Study/Early Termination visit will conclude the Trial. The safety follow-up visit will be scheduled only for the patients with unresolved Adverse Events detected prior or at the End of Study/Early Termination visit. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Behavioral Symptoms
• Dementia

• NCT number: NCT00375557
• Study type: Interventional
• Source: University of Cincinnati
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 2006
• Completion date: September 2007