Randomized Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
- Conditions
- Parkinson DiseaseMild Cognitive Impairment
- Interventions
- Drug: Placebo
- Registration Number
- NCT05709301
- Lead Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Age 50-80
- PD diagnosis according to MDS criteria
- Hoehn and Yahr stage I-III
- Persistent subjective cognitive complaints for at least 6 months
- MDS PD-MCI Level I and Level II criteria
- Persistent PD-MCI for at least 3 months
- Stable dopaminergic treatment for at least 1 month
- PD dementia criteria
- Severe motor complications
- DBS or any brain condition that may be contributing to cognitive impairment
- Active psychosis, major hallucinations, HADS ≥11, active impulse control disorder, or other active severe behavioral disorders.
- Treatment under anticholinergics, cholinergic enhancers, or neuroleptics.
- History of symptomatic arterial hypotension.
- Hypersensitivity or intolerance to donepezil or any of the excipients
- Pregnancy
- Unstable medical or surgical condition
- Any other significant observation that, in the investigator's opinion, would contraindicate participation in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Donepezil Donepezil Hydrochloride -
- Primary Outcome Measures
Name Time Method Parkinson's Disease-Cognitive Rating Scale (PD-CRS) 12 months Global cognition
Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS) 12 months Cognitive functional performance
- Secondary Outcome Measures
Name Time Method TMT-B 12 months Executive functions
Rey-Osterrieth complex figure test (ROCF) 12 months Visuospatial
Trail Making Test A (TMT-A) 12 months Attention
Boston Naming Test 12 months Language
Free and cued selective reminding test 12 months Memory
CGI-Global improvement 12 months Subjective clinical change
Judgment of Line Orientation 12 months Visuspatial
recall of ROCF 12 months Memory
Phonemic Fluency 12 months Executive functions
direct Digit Span 12 months Attention
Hospital Anxiety and Depression Scale 12 months Depression and Anxiety
Clinical Global Impressions-Severity of illness 12 months Subjective clinical change
8-item Parkinson's Disease Questionnaire 12 months Quality of life
Starkstein Apathy scale 12 months Apathy
Neuropsychiatric Inventory 12 months Hallucinations
Patient Global Impression of Change 12 months Subjective clinical change
Category fluency 12 months Language
Schwab & England scale 12 months Quality of life