NCT00476372

Brief Summary

Background: Approximately 40% of patients with Parkinson's disease (PD) have cognitive impairments. There is a lack of consensus as to the extent to which psychiatric symptoms, depression, age at disease onset, disease duration, and medication is related to the type and severity of cognitive impairment. This discrepancy can in part be caused by the lack of distinction between patients with different motor symptoms and disease severity. Objective: To identify the extent to which psychiatric symptoms, depression, age at disease onset, disease duration, and medication is related to the severity and type of cognitive dysfunction in patients with idiopathic PD categorized according to motor symptoms and disease severity. Methods: the population of patients with PD in the old county of Aarhus is described on the background of medical records, and stratified in accordance to age, sex and cardinal symptoms. Through proportional allocation a sample of a minimum of 50 patients with PD is drawn from the population. The patients and 30 healthy matched controls will undergo comprehensive neuropsychological assessment including tests of language, memory, executive function, and visuospatial function. Furthermore, all participants will be screened for depression (Geriatric Depression Scale) and psychiatric symptoms (Neuropsychiatric Inventory and Symptom Checklist). The patients will be categorized in accordance with their motor symptoms via cluster analysis for the purpose of analyzing the effect of psychiatric symptoms, depression, and age of disease onset, disease duration, and medication on cognition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2007

Longer than P75 for all trials

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

May 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

4.3 years

First QC Date

May 21, 2007

Last Update Submit

January 11, 2013

Conditions

Keywords

neuropsychologycognitive impairmentmotor disorderparkinson's disease

Outcome Measures

Primary Outcomes (1)

  • cognitive measures

    1 hour

Study Arms (1)

Parkinson's disease

Pt with parkinsons disease

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

77 patients with PD and 30 healthy control participants

You may qualify if:

  • Idiopathic Parkinson's in accordance to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria,
  • Born and raised in Denmark ,
  • \>50 years

You may not qualify if:

  • Cerebrovascular disease,
  • Dementia not caused by Parkinson's Disease,
  • Metabolism anomaly,
  • Abuse of drugs, medication or alcohol,
  • History of head injuries,
  • Severe psychiatric disorder, excluding depression,
  • Resident outside the region of Aarhus h) DBS -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus Universitetshospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Parkinson DiseaseCognitive DysfunctionMotor Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Karen Østergaard, neurologist

    Aarhus University Hospital

    STUDY CHAIR
  • Lars Larsen, MSc, PhD, Associate Professor

    The Institute of Psychology

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2007

First Posted

May 22, 2007

Study Start

August 1, 2007

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 14, 2013

Record last verified: 2013-01

Locations