Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Indianapolis, Indiana 46202


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.


Study summary:

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.


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


NCT ID:

NCT00182884


Primary Contact:

Principal Investigator
Malaz Boustani, MD, MPH
Regenstrief Institute, Indiana University Center for Aging Research


Backup Contact:

N/A


Location Contact:

Indianapolis, Indiana 46202
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.