Cognitive Impairment in Parkinson's Disease Categorised in Accordance to Motor Symptoms

Parkinson's Disease Clinical Trial

Official title:

Cognitive Impairment in Parkinson's Disease Categorised in Accordance to Motor Symptoms -the Relation Between Cognitive Deficits and Comorbid Psychiatric Disorders, Medication, and Age at Disease Onset

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476372
• Other study ID #: UAarhus
• Status: Completed
• Phase: N/A
• First received: May 21, 2007
• Last updated: January 11, 2013
• Start date: August 2007
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Idiopathic Parkinson's in accordance to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria,

• Born and raised in Denmark ,

• >50 years

Exclusion Criteria:

• 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 -

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cognition Disorders
• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
Denmark	Aarhus Universitetshospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive measures		1 hour	No