NCT00182884

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

March 3, 2008

Status Verified

February 1, 2008

Enrollment Period

2.8 years

First QC Date

September 9, 2005

Last Update Submit

February 28, 2008

Conditions

Postoperative ComplicationsDelirium

Keywords

Hospital acquired complicationsadverse effectsCognitive ImpairmentAging

Outcome Measures

Primary Outcomes (2)

  • 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 (6)

  • 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

  • +1 more secondary outcomes

Interventions

DonepezilDRUG

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Hospital, Clarian Health Partners

Indianapolis, Indiana, 46202, United States

Location

Related Publications (6)

  • 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.

    PMID: 2240918BACKGROUND

  • 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.

    PMID: 1421796BACKGROUND

  • 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.

    PMID: 2302881BACKGROUND

  • Barrett-Connor E. The economic and human costs of osteoporotic fracture. Am J Med. 1995 Feb 27;98(2A):3S-8S. doi: 10.1016/s0002-9343(05)80037-3. No abstract available.

    PMID: 7709931BACKGROUND

  • 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. doi: 10.1002/gps.327.

    PMID: 11333420BACKGROUND

  • 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. doi: 10.1111/j.1532-5415.1988.tb04023.x.

    PMID: 2897391BACKGROUND

MeSH Terms

Conditions

Postoperative ComplicationsDeliriumCognitive Dysfunction

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsNeurocognitive DisordersMental DisordersCognition Disorders

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Malaz Boustani, MD, MPH

    Regenstrief Institute, Indiana University Center for Aging Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

July 1, 2004

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

March 3, 2008

Record last verified: 2008-02

Locations

US(1)