Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05709301
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-28
First Post:
2023-01-11
Brief Title:
Randomized Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinsons Disease
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
Official Title:
Multicenter Randomized Double-blinded Placebo-controlled Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinsons Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
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:
Phase II multi-centric randomized double-blinded placebo-controlled parallel design clinical trial to evaluate the safety tolerability and efficacy of Donepezil in patients with Mild Cognitive Impairment in Parkinsons Disease PD-MCI A total of 120 patients with PD-MCI will be randomized to 12 months of oral Donepezil 10mg or matching placebo 11
Primary and co-primary efficacy endpoints are cognitive and functional cognitive scales PD-CRS and PD-CFRS Secondary efficacy endpoints include cognitive tests evaluating attention executive functions language memory and visuospatial domain mood anxiety and apathy scales questionnaires to evaluate quality of life and subjective impression scales Serum Neurofilament light chain genetic screening of GBA ApoE and MAPT and Magnetic Resonance Imaging will be performed in a subset of these patients
The study will be conducted in 20 different centers around Spain The Movement Disorders Unit of the Neurology Department at Sant Pau Hospital Barcelona Spain will be the coordinating center
Primary and co-primary efficacy endpoints are cognitive and functional cognitive scales PD-CRS and PD-CFRS Secondary efficacy endpoints include cognitive tests evaluating attention executive functions language memory and visuospatial domain mood anxiety and apathy scales questionnaires to evaluate quality of life and subjective impression scales Serum Neurofilament light chain genetic screening of GBA ApoE and MAPT and Magnetic Resonance Imaging will be performed in a subset of these patients
The study will be conducted in 20 different centers around Spain The Movement Disorders Unit of the Neurology Department at Sant Pau Hospital Barcelona Spain will be the coordinating center
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None