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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Donepezil 10mg once daily
Matching placebo
Parkinson's Disease-Cognitive Rating Scale (PD-CRS)
Global cognition
Time frame: 12 months
Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS)
Cognitive functional performance
Time frame: 12 months
Trail Making Test A (TMT-A)
Attention
Time frame: 12 months
TMT-B
Executive functions
Time frame: 12 months
Boston Naming Test
Language
Time frame: 12 months
Free and cued selective reminding test
Memory
Time frame: 12 months
Rey-Osterrieth complex figure test (ROCF)
Visuospatial
Time frame: 12 months
Hospital Anxiety and Depression Scale
Depression and Anxiety
Time frame: 12 months
Starkstein Apathy scale
Apathy
Time frame: 12 months
Neuropsychiatric Inventory
Hallucinations
Time frame: 12 months
Schwab & England scale
Quality of life
Time frame: 12 months
Clinical Global Impressions-Severity of illness
Subjective clinical change
Time frame: 12 months
CGI-Global improvement
Subjective clinical change
Time frame: 12 months
Patient Global Impression of Change
Subjective clinical change
Time frame: 12 months
8-item Parkinson's Disease Questionnaire
Quality of life
Time frame: 12 months
Judgment of Line Orientation
Visuspatial
Time frame: 12 months
recall of ROCF
Memory
Time frame: 12 months
Category fluency
Language
Time frame: 12 months
Phonemic Fluency
Executive functions
Time frame: 12 months
direct Digit Span
Attention
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.