Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-27 @ 12:35 AM
Study NCT ID:
NCT00375557
Status:
WITHDRAWN
Last Update Posted:
2015-05-27
First Post:
2006-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Divalproex and Quetiapine in Elderly Alzheimer's Dementia Patients
Sponsor:
University of Cincinnati
Organization:
Study Overview
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WITHDRAWN
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: