Behavioural Profiling of Disease-related Cognitive and Motor Impairment in PD

Depression Clinical Trial

Official title:

Behavioural Profiling of Disease-related Cognitive and Motor Impairment With Focus on Dopaminergic Effects in Parkinson's Disease and Potential Correlation to Biomarkers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06275633
• Other study ID #: H-18055648
• Status: Completed
• Phase: N/A
• Start date: March 19, 2019
• Est. completion date: July 30, 2023

Study information

• Verified date: February 2024
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this project, patients with Parkinson's Disease (PD) will be characterized by measuring cognitive and motor function and relation to effect of Levodopa.

Participants will be patients with Parkinson's Disease and healthy controls. It will be investigated if there is a difference between patients with a good measured Levodopa response and with a poor measured response.

Description:

The patients with Parkinson's Disease will be included from the outpatient clinic at the Department of Neurology at Bispebjerg Frederiksberg Hospital and healthy controls will be found among relatives or volunteers through research ads.

Patients will be asked to pause dopaminergic medication for 6 half times.Then a baseline examination will be performed in the morning in a non-medicated state (OFF), using Unified Parkinson's disease rating Scale (UPDRS), the MOntreal Cognitive Assessment (MoCA) and computerized cognitive testing. Baseline screening for depression with Beck Depression Inventory (BDI) and for impulsivity with Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP).

An acute levodopa challenge will be performed with patients receiving 200/25 mg dispersible levodopa/benserazide. After an hour UPDRS and cognitive computerized tests are repeated.

This is estimated to take about 3½ hours to complete. In healthy controls a neurological examination, BDI and MoCA will pe performed.

The UPDRS motor test is videotaped. A specialist will later evaluate the motor function blinded.

The participants will be asked to participate in the Bispebjerg Frederiksberg (BFH) BioBank, BFH-2017-114, (ISuite nr.: 05991) at Bispebjerg Frederiksberg Hospital for future research.

An exact calculation of power is difficult to calculate as the project includes a broad range of correlations.

Numeric data will be analysed using the Student's t-test (when normal distribution is met) or Wilcoxon rank sum test (when normal distribution is not met). Binary data will be analysed using the Fishers exact test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 30, 2023
• Est. primary completion date: December 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age of minimum 18

• Diagnosis of PD

• Be able to cooperate, understand and participate in the project

• Signed informed consent, including consent to being included in the Biobank

Exclusion Criteria:

• Dementia

• Treatment with anti-dopaminergic medication.

Related Conditions & MeSH terms

• Cognitive Impairment
• Depression
• Levodopa
• Medication
• Motor Function
• Parkinson Disease
• UPDRS

Intervention

Drug:
• Levodopa
Medicine response

Locations

Country	Name	City	State
Denmark	University Hospital Bispebjerg and Frederiksberg	Copenhagen	Region Hovedstaden

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Bispebjerg and Frederiksberg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive function	The Montreal Cognitive Assessment (MoCA)	Baseline
Other	Depressive symptoms	BDI, Beck Depression Inventory	Baseline
Other	Impulsivity	QUIP, Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale	Baseline
Primary	Motor improvement	Unified Parkinson's disease rating scale, motor part (UPDRS-3) OFF medication compared to ON medication	Baseline to end of Levodopa challenge test, approximately 3-4 hours
Secondary	Cognitive function	Cognitive computer tests	Baseline to end of Levodopa challenge test, approximately 3-4 hours