Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-28 @ 4:03 AM
Study NCT ID:
NCT00711204
Status:
WITHDRAWN
Last Update Posted:
2012-12-10
First Post:
2008-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating The Impact Of Donepezil Hydrochloride (Aricept) On Behavioral And Psychological Symptoms In Patients With Severe Alzheimer's Disease
Sponsor:
Eisai Inc.
Organization:
Study Overview
Official Title:
A 12-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Impact Of Donepezil Hydrochloride (Aricept) On Behavioral And Psychological Symptoms In Patients With Severe Alzheimer's Disease
Status:
WITHDRAWN
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No patients were enrolled in the study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A 12-week, multicenter, randomized, double-blind, placebo-controlled phase IV study. Approximately 200 subjects will be enrolled, half will receive active drug (donepezil hydrochloride) and half will receive matching placebo at approximately 50 research sites within the US, the European Union, South Africa and Australia. Eligible subjects will reside at home, in an assisted living facility, or nursing homes age and will be 50 years or older, with a diagnosis of Alzheimer's disease in the severe stage. All subjects must start with 5mg a day (one 5 mg tablet of donepezil HCL or matching placebo). Dose will be increased to 10 mg a day (two tablets of 5 mg donepezil HCL or matching placebo) after 4 weeks. Dose may be decreased based on side effects. The primary efficacy measure will be the Cornell Scale for Depression in Dementia (CSDD). Secondary measures will include Functional Assessment Staging (FAST), Mini-Mental State Examination (MMSE), NPI-10 (Neuropsychiatric Inventory), DEMQOL Proxy ( Quality of Life). Blood levels of cytokines and safety will also be assessed.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: