Behavioural Profiling of Disease-related Cognitive and Motor Impairment With Focus on Dopaminergic Effects in Parkinson's Disease and Potential Correlation to Biomarkers.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Motor improvement
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •Treatment with anti-dopaminergic medication.
Arms & Interventions
Effect of levodopa
- Patients with PD are first being tested "off medication"
- After examination OFF, the same group is being tested after adm of 200 mg Madopar Q
Intervention: Levodopa (Drug)
Outcomes
Primary Outcomes
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
- Cognitive function(Baseline to end of Levodopa challenge test, approximately 3-4 hours)
Investigators
Annemette Lokkegaard
Associate professor
University Hospital Bispebjerg and Frederiksberg