Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-29 @ 9:08 AM
Study NCT ID:
NCT06275633
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2023-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioural Profiling of Disease-related Cognitive and Motor Impairment in PD
Sponsor:
University Hospital Bispebjerg and Frederiksberg
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: