Loading clinical trials...
Loading clinical trials...
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.
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.
Age
18 - 90 years
Sex
ALL
Healthy Volunteers
Yes
University Hospital Bispebjerg and Frederiksberg
Copenhagen, Capital Region, Denmark
Start Date
March 19, 2019
Primary Completion Date
December 3, 2021
Completion Date
July 30, 2023
Last Updated
February 23, 2024
68
ACTUAL participants
Levodopa
DRUG
Lead Sponsor
University Hospital Bispebjerg and Frederiksberg
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04246437