Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06275633
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2023-09-14
Brief Title:
Behavioural Profiling of Disease-related Cognitive and Motor Impairment in PD
Sponsor:
University Hospital Bispebjerg and Frederiksberg
Organization:
University Hospital Bispebjerg and Frederiksberg
Study Overview
Official Title:
Behavioural Profiling of Disease-related Cognitive and Motor Impairment With Focus on Dopaminergic Effects in Parkinsons 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 Parkinsons Disease PD will be characterized by measuring cognitive and motor function and relation to effect of Levodopa
Participants will be patients with Parkinsons 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 Parkinsons 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 Parkinsons 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 timesThen a baseline examination will be performed in the morning in a non-medicated state OFF using Unified Parkinsons 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 Parkinsons Disease-Rating Scale QUIP
An acute levodopa challenge will be performed with patients receiving 20025 mg dispersible levodopabenserazide 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 Students 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 timesThen a baseline examination will be performed in the morning in a non-medicated state OFF using Unified Parkinsons 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 Parkinsons Disease-Rating Scale QUIP
An acute levodopa challenge will be performed with patients receiving 20025 mg dispersible levodopabenserazide 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 Students 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?:
None