Ignite Creation Date:
2024-05-06 @ 8:06 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02660983
Status:
COMPLETED
Last Update Posted:
2020-01-10
First Post:
2016-01-18
Brief Title:
A Study of Donepezil Hydrochloride in Patients With Dementia Associated With Cerebrovascular Disease
Sponsor:
Eisai Co Ltd
Organization:
Eisai Inc
Study Overview
Official Title:
A Multi-Center Randomized Double-Blind Placebo-Controlled Parallel-Group Study of Donepezil Hydrochloride E2020 in Patients With Dementia Associated With Cerebrovascular Disease
Status:
COMPLETED
Status Verified Date:
2018-05
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 objectives are to confirm that donepezil hydrochloride has superior efficacy compared with placebo in improving cognitive function as measured by Alzheimers Disease Assessment Scale-Cognitive subscale ADAS-cog and to demonstrate that donepezil hydrochloride has superior efficacy compared with placebo in improving global function as measured by Clinicians Interview-Based Impression of Change-plus Caregiver Input CIBIC-plus in patients with dementia associated with cerebrovascular disease VaD
Detailed Description:
This is a multi-center randomized double-blind placebo-controlled parallel-group study with an open-label extension The study consists of 3 phases screening phase 1 to 4 weeks double-blind phase 24 weeks and Open-label extension phase 24 weeks Participants who have completed the double-blind phase and want to continue the study participation can be enrolled in the 24-week open-label extension phase
Study Oversight
Has Oversight DMC:
None
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?:
None