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

February 15, 2024 updated by: Annemette Lokkegaard, University Hospital Bispebjerg and Frederiksberg

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Hovedstaden
      • Copenhagen, Region Hovedstaden, Denmark, 2400
        • University Hospital Bispebjerg and Frederiksberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Effect of 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
Drug: Levodopa
Medicine response

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor improvement
Time Frame: 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
Baseline to end of Levodopa challenge test, approximately 3-4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function
Time Frame: Baseline to end of Levodopa challenge test, approximately 3-4 hours
Cognitive computer tests
Baseline to end of Levodopa challenge test, approximately 3-4 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function
Time Frame: Baseline
The Montreal Cognitive Assessment (MoCA)
Baseline
Depressive symptoms
Time Frame: Baseline
BDI, Beck Depression Inventory
Baseline
Impulsivity
Time Frame: Baseline
QUIP, Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Bispebjerg and Frederiksberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2019

Primary Completion (Actual)

December 3, 2021

Study Completion (Actual)

July 30, 2023

Study Registration Dates

First Submitted

September 14, 2023

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-18055648

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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