A Study of Donepezil Hydrochloride in Patients With Dementia Associated With Cerebrovascular Disease
Summary
The primary objectives are to confirm that donepezil hydrochloride has superior efficacy compared with placebo in improving cognitive function, as measured by Alzheimer's 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 Clinician's Interview-Based Impression of Change-plus Caregiver Input (CIBIC-plus), in patients with dementia associated with cerebrovascular disease (VaD).
Timeline
- Start
- 2013-08-05
- Primary completion
- 2018-07-13
- Completion
- 2018-12-21
Outcome
Missed primary endpoint
registry analysis (superiority test); Double Blind (DB) Phase: Placebo vs Double Blind (DB) Phase: Donepezil; p = 0.3455 NCT02660983 ↗
registry analysis (superiority test); Double Blind (DB) Phase: Placebo vs Double Blind (DB) Phase: Donepezil; p = 0.2570 NCT02660983 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Donepezil | Small molecule | 5 mg | — |
| Subject | Donepezil | Small molecule | 10 mg | — |