Randomized Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Multicenter, Randomized, Double-blinded, Placebo-controlled Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05709301
• Other study ID #: IIBSP-DON-2022-43
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 1, 2023
• Est. completion date: November 1, 2025

Study information

• Verified date: September 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment
• Parkinson Disease

Intervention

Drug:
• Donepezil Hydrochloride
Donepezil 10mg once daily
• Placebo
Matching placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parkinson's Disease-Cognitive Rating Scale (PD-CRS)	Global cognition	12 months
Primary	Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS)	Cognitive functional performance	12 months
Secondary	Trail Making Test A (TMT-A)	Attention	12 months
Secondary	TMT-B	Executive functions	12 months
Secondary	Boston Naming Test	Language	12 months
Secondary	Free and cued selective reminding test	Memory	12 months
Secondary	Rey-Osterrieth complex figure test (ROCF)	Visuospatial	12 months
Secondary	Hospital Anxiety and Depression Scale	Depression and Anxiety	12 months
Secondary	Starkstein Apathy scale	Apathy	12 months
Secondary	Neuropsychiatric Inventory	Hallucinations	12 months
Secondary	Schwab & England scale	Quality of life	12 months
Secondary	Clinical Global Impressions-Severity of illness	Subjective clinical change	12 months
Secondary	CGI-Global improvement	Subjective clinical change	12 months
Secondary	Patient Global Impression of Change	Subjective clinical change	12 months
Secondary	8-item Parkinson's Disease Questionnaire	Quality of life	12 months
Secondary	Judgment of Line Orientation	Visuspatial	12 months
Secondary	recall of ROCF	Memory	12 months
Secondary	Category fluency	Language	12 months
Secondary	Phonemic Fluency	Executive functions	12 months
Secondary	direct Digit Span	Attention	12 months