Cognitive Impairment, Depression, Impulsive, Levodopa, Medication, Motor Function, Parkinson Disease, UPDRS
Conditions
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.
Interventions
DRUGLevodopa
Medicine response
Sponsors
University Hospital Bispebjerg and Frederiksberg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
There will be a blinded assessment of videos of participants with Parkinson's Disease ON and OFF medication
Intervention model description
This is a prospective patient with Parkinson's Disease cohort. After acute levodopa challenge test patients with Parkinson's Disease are divided due to measured levodopa response and their self-rated medicine effect.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function | Baseline to end of Levodopa challenge test, approximately 3-4 hours | Cognitive computer tests |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function | Baseline | The Montreal Cognitive Assessment (MoCA) |
| Depressive symptoms | Baseline | BDI, Beck Depression Inventory |
| Impulsivity | Baseline | QUIP, Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale |
Countries
Denmark
Outcome results
None listed