NCT00375557

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

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• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Alzheimer's Disease
• Dementia
• Behavioral Symptoms

Interventions

Type	Name	Description
DRUG	Divalproex ER	Divalproex ER will be initiated on 250 mg/day, dosed once daily. The daily dose of Divalproex ER will be titrated up 250 mg each day based on patients' response and tolerability, not to exceed a maximum of 2000 mg/day.
DRUG	Quetiapine	Quetiapine will be initiated in 25 mg/day, with a variable dosing frequency (QD-TID). The daily dose of Quetiapine will be titrated up by 25-50 mg each day based on patients' response and tolerability, not to exceed a maximum of 750 mg/day.

Timeline

• Start date: 2006-10-01
• Completion: 2007-09-01
• First posted: 2006-09-13
• Last updated: 2015-05-27

Locations

1 site across 1 country: United States