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

NCT ID: NCT05709301

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-11-01

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.

Conditions

Parkinson Disease; Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Donepezil

Group Type: EXPERIMENTAL

Donepezil Hydrochloride

Intervention Type: DRUG

Donepezil 10mg once daily

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo

Interventions

Donepezil Hydrochloride

Donepezil 10mg once daily

Intervention Type: DRUG

Placebo

Matching placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IIBSP-DON-2022-43

Identifier Type: -

Identifier Source: org_study_id