NCT00220896

Brief Summary

Patients undergoing hip or knee joint replacement at the age of 70 years or above who are cognitively unimpaired will receive donepezil or matching placebo before (over 5-7 days), during and after (over 7 days) surgery. The incidence of delirium will be monitored at 3 days, 7 days, and 49 days following surgery. We hypothesize that the incidence of delirium can be lowered from 20 per cent to 10 per cent by the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2006

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

September 14, 2011

Status Verified

September 1, 2011

First QC Date

September 14, 2005

Last Update Submit

September 13, 2011

Conditions

Cognitively Normal Elderly Individuals

Keywords

DeliriumPreventionDonepezil

Outcome Measures

Primary Outcomes (1)

  • Incidence of delirium

Secondary Outcomes (1)

  • Cognitive performance

Interventions

DonepezilDRUG

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Cognitively healthy, elective hip or knee replacement

You may not qualify if:

  • Ongoing cholinergic treatment, dementia, delirium, acute physical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deps. of Psychiatry and Anaesthesiology, Tech. Universitaet Munich

Munich, D-81675, Germany

Location

MeSH Terms

Conditions

Delirium

Interventions

Donepezil

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Janine Diehl, M. D.

    Dept. of Psychiatry, Technische Universitaet Muenchen

    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 14, 2005

First Posted

September 22, 2005

Study Start

January 1, 2006

Study Completion

March 1, 2009

Last Updated

September 14, 2011

Record last verified: 2011-09

Locations

DE(1)