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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06275633
Other study ID # H-18055648
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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