CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
donepezil +1 moredrug
Likely dose
donepezil 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00586196
NCT00586196Phase 2Completed

Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period

Beth Israel Deaconess Medical Center·interventional·Posted Jan 4, 2008·Updated Aug 22, 2014

In Brief

A Phase 2 clinical trial evaluating donepezil and Placebo for Delirium. Completed, enrolled 16 participants across 1 site.

Detailed Summary

Delirium (acute confusion) is a highly prevalent condition among hospitalized elders with substantial morbidity within the hospital and beyond. Particular patient populations are at high risk for poor outcomes after an episode of delirium. Patients with hip and other long bone fractures are at increased risk of developing delirium (acute confusion) which impedes functional recovery. This is a pilot study to test the tolerability and efficacy of donepezil, a cholinesterase inhibitor medication used commonly in persons with dementia, for the prevention of new or worsening delirium in aged hip and other long-bone fracture patients. Additional purposes involve gathering a small amount of patients' serum to better understand the pathophysiology of delirium in this population. The purposes of this pilot study are to determine: 1) the safety and tolerability a cholinesterase inhibitor medication) in aged hip and long bone fracture patients, 2) To obtain estimates of subject accrual and preliminary estimates of effect size on the development of new delirium symptoms to allow for planning of a larger, definitive trial, 3) To better understand the underlying causes of delirium by examining whether a measure of blood anticholinergic activity relates to the incidence and persistence of delirium symptoms, and 4) To explore the interaction between anticholinergic activity, donepezil therapy, and delirium symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDelirium
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 4, 2008
Enrollment StartJan 1, 2007
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 18.5 years ago

Interventions

donepezildrug

5 mg each day for 30 days

Placebodrug

Encapsulated cornstarch One capsule daily for 30 days