Donepezil in Preventing Delirium in Hospitalized Elderly - Full Text View

Sponsored by:	Clarian Health Partners
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00182884

Purpose

The purpose of this study is to explore the efficacy of a perioperative daily dose of Donepezil (a cholinergic enhancer) in reducing the incidence and severity of delirium.

Condition	Intervention	Phase
Postoperative Complications Delirium	Drug: Donepezil	Phase IV

Drug Information available for: Donepezil E 2020

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Preventing Delirium in Hospitalized Elderly

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

Postoperative cumulative incident cases of delirium, as defined by the Confusion Assessment Method (CAM) administered at baseline prior to surgery and daily until discharge
delirium severity as measured by the Memorial Delirium Assessment Scale (MDAS)

Secondary Outcome Measures:

Cognitive status as measured by the Mini Mental Status Exam (MMSE)
behavioral status using the Rating Scale for Aggressive Behavior in the Elderly (RAGE)
length of stay in hospital postoperatively
discharge site
adverse effects
use of psychotropic medications

Estimated Enrollment:	30
Study Start Date:	July 2004
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Detailed Description:

Delirium is confusion or a sudden change in alertness which may happen after hip repair surgery. Up to 65% of elderly undergoing surgical repair of hip fracture experience post-operative delirium. These individuals often stay in the hospital longer, have more complications, and are more likely to die. Early studies suggest that delirium could be prevented by correcting the central cholinergic deficit that is associated with delirium. Donepezil is currently being used to treat memory loss in patients with Alzheimer's disease.

This study will recruit 30 adults aged 65 or older who are undergoing hip fracture surgery. Participants will be randomized to receive either Donepezil or a matching placebo within 24 hours prior to surgery and for 4 days after the surgery.

All material to be collected will be from interviews, questionnaires, and medical chart review at baseline and daily for the entire hospital stay. The Confusion Assessment Method (CAM) and Memorial Delirium Assessment Scale (MDAS) will be used to evaluate the effect of Donepezil on delirium incidence and severity. Other assessments include cognitive deficit, length of hospitalization, discharge site, adverse effects, and psychotropic medications.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Community-dwelling individuals aged 65 or older
Admitted to Methodist Hospital for surgical repair of hip fracture
No evidence of delirium at admission to hospital
MMSE total score below 24 points after adjustment for education and age
Consent to participate in the study

Exclusion Criteria:

Severely demented as defined by MMSE score below 10
Metastatic cancer or other comorbid illnesses likely to reduce life expectancy to under 6 months
Multiple trauma or pathological fractures
Aphasic, legally blind, or deaf
Use of Donepezil or other cholinesterase inhibitors within one month prior to surgery
Allergy to Donepezil

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182884

Locations

United States, Indiana
Methodist Hospital, Clarian Health Partners
Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Clarian Health Partners

Investigators

Principal Investigator:

Malaz Boustani, MD, MPH

Regenstrief Institute, Indiana University Center for Aging Research

More Information

Publications:

Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8.

Cooper C, Campion G, Melton LJ 3rd. Hip fractures in the elderly: a world-wide projection. Osteoporos Int. 1992 Nov;2(6):285-9.

Cummings SR, Rubin SM, Black D. The future of hip fractures in the United States. Numbers, costs, and potential effects of postmenopausal estrogen. Clin Orthop Relat Res. 1990 Mar;(252):163-6.

Barrett-Connor E. The economic and human costs of osteoporotic fracture. Am J Med. 1995 Feb 27;98(2A):3S-8S. Review. No abstract available.

Galanakis P, Bickel H, Gradinger R, Von Gumppenberg S, Forstl H. Acute confusional state in the elderly following hip surgery: incidence, risk factors and complications. Int J Geriatr Psychiatry. 2001 Apr;16(4):349-55.

Gustafson Y, Berggren D, Brannstrom B, Bucht G, Norberg A, Hansson LI, Winblad B. Acute confusional states in elderly patients treated for femoral neck fracture. J Am Geriatr Soc. 1988 Jun;36(6):525-30.

Study ID Numbers:	IA0079, VFR-161
Study First Received:	September 9, 2005
Last Updated:	February 28, 2008
ClinicalTrials.gov Identifier:	NCT00182884
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Hospital acquired complications
adverse effects
Cognitive Impairment
Aging

Study placed in the following topic categories:

Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Postoperative Complications
Mental Disorders
Donepezil
Neurologic Manifestations

Confusion
Dementia
Neurobehavioral Manifestations
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nootropic Agents
Cholinesterase Inhibitors
Neurotransmitter Agents
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Physiological Effects of Drugs
Nervous System Diseases
Enzyme Inhibitors
Cholinergic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009