Mild Cognitive Impairment, Parkinson Disease
Conditions
Keywords
Parkinson's Disease-Mild Cognitive Impairment (PD-MCI), Donepezil, Randomized Clinical Trial (RCT)
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.
Interventions
DRUGDonepezil Hydrochloride
Donepezil 10mg once daily
DRUGPlacebo
Matching placebo
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| TMT-B | 12 months | Executive functions |
| Boston Naming Test | 12 months | Language |
| Free and cued selective reminding test | 12 months | Memory |
| Rey-Osterrieth complex figure test (ROCF) | 12 months | Visuospatial |
| Hospital Anxiety and Depression Scale | 12 months | Depression and Anxiety |
| Starkstein Apathy scale | 12 months | Apathy |
| Neuropsychiatric Inventory | 12 months | Hallucinations |
| Clinical Global Impressions-Severity of illness | 12 months | Subjective clinical change |
| Schwab & England scale | 12 months | Quality of life |
| Patient Global Impression of Change | 12 months | Subjective clinical change |
| 8-item Parkinson's Disease Questionnaire | 12 months | Quality of life |
| Judgment of Line Orientation | 12 months | Visuspatial |
| recall of ROCF | 12 months | Memory |
| Category fluency | 12 months | Language |
| Phonemic Fluency | 12 months | Executive functions |
| direct Digit Span | 12 months | Attention |
| CGI-Global improvement | 12 months | Subjective clinical change |
| Trail Making Test A (TMT-A) | 12 months | Attention |
Outcome results
None listed