Clinical trial NCT05709301: Randomized Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Official title: Multicenter, Randomized, Double-blinded, Placebo-controlled Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Parkinson Disease
Mild Cognitive Impairment
Keywords: Parkinson's Disease-Mild Cognitive Impairment (PD-MCI)
Donepezil
Randomized Clinical Trial (RCT)
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Parkinson's Disease-Cognitive Rating Scale (PD-CRS)
timeFrame: 12 months
measure: Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS)
timeFrame: 12 months
Secondary outcomes:
measure: Trail Making Test A (TMT-A)
timeFrame: 12 months
measure: TMT-B
timeFrame: 12 months
measure: Boston Naming Test
timeFrame: 12 months
measure: Free and cued selective reminding test
timeFrame: 12 months
measure: Rey-Osterrieth complex figure test (ROCF)
timeFrame: 12 months
measure: Hospital Anxiety and Depression Scale
timeFrame: 12 months
measure: Starkstein Apathy scale
timeFrame: 12 months
measure: Neuropsychiatric Inventory
timeFrame: 12 months
measure: Schwab & England scale
timeFrame: 12 months
measure: Clinical Global Impressions-Severity of illness
timeFrame: 12 months
measure: CGI-Global improvement
timeFrame: 12 months
measure: Patient Global Impression of Change
timeFrame: 12 months
measure: 8-item Parkinson's Disease Questionnaire
timeFrame: 12 months
measure: Judgment of Line Orientation
timeFrame: 12 months
measure: recall of ROCF
timeFrame: 12 months
measure: Category fluency
timeFrame: 12 months
measure: Phonemic Fluency
timeFrame: 12 months
measure: direct Digit Span
timeFrame: 12 months
Other outcomes:
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