Foundation Research Institute of the Hospital de la Santa Creu i Sant Pau
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 Parkinson's Disease (PD-MCI). A total of 120 patients with PD-MCI will be randomized to 12 months of oral Donepezil 10mg or matching placebo (1:1). 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.
Parkinson Disease
Mild Cognitive Impairment
Donepezil Hydrochloride
Placebo
Phase 2
Study Type : | Interventional |
Estimated Enrollment : | 120 participants |
Masking : | Quadruple |
Primary Purpose : | Treatment |
Official Title : | Multicenter, Randomized, Double-blinded, Placebo-controlled Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease |
Actual Study Start Date : | October 1, 2023 |
Estimated Primary Completion Date : | November 1, 2025 |
Estimated Study Completion Date : | November 1, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Donepezil |
Drug: Donepezil Hydrochloride |
Placebo Comparator: Placebo |
Drug: Placebo |
Ages Eligible for Study: | 50 Years to 80 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.