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Completed

NCT Number: NCT06275633

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

levodopa

Drug

Medicine response

Primary outcomes

  1. 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

Secondary outcomes

  1. Cognitive function

    Time frame: Baseline to end of Levodopa challenge test, approximately 3-4 hours

    Cognitive computer tests

Other outcomes

  1. Cognitive function

    Time frame: Baseline

    The Montreal Cognitive Assessment (MoCA)

  2. Depressive symptoms

    Time frame: Baseline

    BDI, Beck Depression Inventory

  3. Impulsivity

    Time frame: Baseline

    QUIP, Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale

Sponsors and collaborators

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Feb 23, 2024
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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