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Sponsors and Collaborators: |
Beth Israel Deaconess Medical Center National Institute on Aging (NIA) |
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Information provided by: | Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT00586196 |
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.
Condition | Intervention | Phase |
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Delirium |
Drug: donepezil Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period |
Estimated Enrollment: | 40 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: donepezil
5 mg each day for 30 days
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2: Placebo Comparator |
Drug: Placebo
Encapsulated cornstarch One capsule daily for 30 days
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Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Margaret A Bergmann, MS | 617-667-4223 | mbergma1@bidmc.harvard.edu |
Contact: Kerrry Clark, BS | 617-632-8844 | kaclark@bidmc.harvard.edu |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Principal Investigator: Edward R Marcantonio, MD |
Principal Investigator: | Edward R Marcantonio, MD | Beth Israel Deaconess Medical Center |
Responsible Party: | Beth Israel Deaconess Medical Center ( Edward R. Marcantonio, MD ) |
Study ID Numbers: | 2006p-000193, R21AG027549 |
Study First Received: | December 21, 2007 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00586196 |
Health Authority: | United States: Food and Drug Administration |
Delirium Postoperative confusion Hip fracture Long bone fracture |
Signs and Symptoms Hip Fractures Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil Fractures, Bone |
Neurologic Manifestations Confusion Dementia Neurobehavioral Manifestations Cognition Disorders Delirium |
Nervous System Diseases |