Donepezil in Preventing Delirium in Hospitalized Elderly

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00182884
First received: September 9, 2005
Last updated: February 28, 2008
Last verified: February 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Preventing Delirium in Hospitalized Elderly

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by National Institute on Aging (NIA):
Hospital acquired complications
adverse effects
Cognitive Impairment
Aging

Additional relevant MeSH terms:
Delirium
Postoperative Complications
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Pathologic Processes
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014