Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period

NCT00586196 | Completed Phase 2 Results DMC

• 2 other identifiers: 2006p-000193R21AG027549
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delirium

Keywords

Delirium; Postoperative confusion; Hip fracture; Long bone fracture

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Delirium Using the CAM Over Time

  Confusion Assessment Method (CAM)-Measure of the presence or absence of delirium. Requires 1) acute change with fluctuating course, 2) inattention, and either 3) disorganized thinking or 4) altered level of consciousness.

  Baseline, hospital interviews, weeks 2, 4 and 6

Secondary Outcomes (1)

• Change From Baseline and MDAS Scores Over Time

  Baseline, hospital discharge, weeks 2, 4 and 6

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: donepezil

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

donepezil DRUG

5 mg each day for 30 days

Also known as: Aricept

1

Placebo DRUG

Encapsulated cornstarch One capsule daily for 30 days

2

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• hip or other long bone fracture undergoing operative repair
• age of 70 years or older
• the ability to communicate effectively in English (including adequate hearing)
• residence within a 50 mile radius of the BIDMC
• life expectancy 6 months or greater
• not currently on cholinesterase inhibitor therapy
• not with known hypersensitivity to cholinesterase inhibitors
• not a previous study participant or refusal

You may not qualify if:

• patients with sick sinus syndrome or greater than 1st degree AV block without a pacemaker
• patients with a pathologic fracture due to metastatic cancer
• patients with advanced dementia or total functional dependence.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Marcantonio ER, Palihnich K, Appleton P, Davis RB. Pilot randomized trial of donepezil hydrochloride for delirium after hip fracture. J Am Geriatr Soc. 2011 Nov;59 Suppl 2(Suppl 2):S282-8. doi: 10.1111/j.1532-5415.2011.03691.x.

  PMID: 22091574 RESULT

MeSH Terms

Conditions

Delirium; Hip Fractures

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Edward R Marcantonio
• Organization: BIDMC

emarcant@bidmc.harvard.edu

617-754-1405

Study Officials

• Edward R Marcantonio, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 4, 2008
• Study Start: January 1, 2007
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 22, 2014
• Results First Posted: August 22, 2014

Record last verified: 2014-08

Locations

US (1)