Clinical trial NCT06275633: Behavioural Profiling of Disease-related Cognitive and Motor Impairment in PD
Official title: Behavioural Profiling of Disease-related Cognitive and Motor Impairment With Focus on Dopaminergic Effects in Parkinson's Disease and Potential Correlation to Biomarkers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Medication
UPDRS
Motor Function
Cognitive Impairment
Depression
Impulsive
Levodopa
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Motor improvement
timeFrame: Baseline to end of Levodopa challenge test, approximately 3-4 hours
Secondary outcomes:
measure: Cognitive function
timeFrame: Baseline to end of Levodopa challenge test, approximately 3-4 hours
Other outcomes:
measure: Cognitive function
timeFrame: Baseline
measure: Depressive symptoms
timeFrame: Baseline
measure: Impulsivity
timeFrame: Baseline
Locations:
city: Copenhagen
country: Denmark
facility: University Hospital Bispebjerg and Frederiksberg
state: Region Hovedstaden
Study officials:
References: