Donepezil in Preventing Delirium in Hospitalized Elderly | NCT00182884

Studies
Donepezil in Preventing Delirium in Hospitalized Elderly

NCT00182884

Sponsor

Indiana University Health

Status

Completed

Last Update Posted

Mar 3, 2008Estimated

Enrollment

Phase

Phase 4

Conditions

Postoperative Complications
Delirium

Interventions

Donepezil

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
VFR-161

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2004

Primary Completion Date

Apr 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2008

Last Update Posted Date

Mar 3, 2008Estimated

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Donepezil	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Cognitive status as measured by the Mini Mental Status Exam (MMSE)
behavioral status using the Rating Scale for Aggressive Behavior in the Elderly (RAGE)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Methodist Hospital, Clarian Health Partners		Indianapolis	Indiana	46202	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
2240918	Background	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. doi: 10.7326/0003-4819-113-12-941.
1421796	Background	Cooper C, Campion G, Melton LJ 3rd. Hip fractures in the elderly: a world-wide projection. Osteoporos Int. 1992 Nov;2(6):285-9. doi: 10.1007/BF01623184.

ID	Term
D011183	Postoperative Complications
D003693	Delirium
D060825	Cognitive Dysfunction

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D003221	Confusion
D019954	Neurobehavioral Manifestations

ID	Term
D007189	Indans
D007192	Indenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic