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

Not Applicable

Completed

• Conditions: Depression; Levodopa; Parkinson Disease; Medication; Cognitive Impairment; UPDRS; Motor Function; Impulsive
• Interventions: Drug: Levodopa

• Registration Number: NCT06275633
• Lead Sponsor: University Hospital Bispebjerg and Frederiksberg

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-03-19
• Primary Completion: 2021-12-03
• Study Completion: 2023-07-30
• Study First Submitted: 2023-09-14
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Effect of levodopa	Levodopa	1. Patients with PD are first being tested "off medication" 2. After examination OFF, the same group is being tested after adm of 200 mg Madopar Q

Primary Outcome Measures

Name	Time	Method
Motor improvement	Baseline to end of Levodopa challenge test, approximately 3-4 hours	Unified Parkinson's disease rating scale, motor part (UPDRS-3) OFF medication compared to ON medication

Secondary Outcome Measures

Name	Time	Method
Cognitive function	Baseline to end of Levodopa challenge test, approximately 3-4 hours	Cognitive computer tests

Trial Locations

Locations (1)

University Hospital Bispebjerg and Frederiksberg; 🇩🇰 Copenhagen, Region Hovedstaden, Denmark