Trial intelligence / Profile preview

Donepezil for POCD prevention in elderly

NCT00182845Phase 4

Key facts

Status: Completed
Start: Feb 2005
Primary completion: Apr 2007
Countries: 1
Sponsor: Pfizer
Modality: Small Molecules

Drugs: donepezil
Conditions: Post-operative cognitive dysfunction (POCD)

Overview

Phase 4, randomised, double-blind trial in Post-operative cognitive dysfunction (POCD) comparing Donepezil with Placebo (2 arms). Primary endpoint: Changes in the International Study of Post-Operative Cognitive Decline (ISPOCD) and the CogHealth computerized battery tests at 12 weeks. Started Feb 2005; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Donepezil
Donepezil supply for 3-6 weeks starting 4 weeks pre-op
Placebo
Matching placebo supply for 3-6 weeks starting 4 weeks pre-op

Endpoints

Primary

Changes in the International Study of Post-Operative Cognitive Decline (ISPOCD) and the CogHealth computerized battery tests12 weeks

Secondary

Delirium status measured by the Confusion Assessment Method (CAM) and the Memorial Delirium Assessment Scale (MDAS)daily post-operative
Global cognitive status assessed using the Mini Mental Status Exam (MMSE)post-operative
Length of stay in the hospital post-operativelypost-operative
Discharge sitedischarge
Adverse effectsthroughout study

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