NCT05709301

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_2 parkinson-disease

Timeline
Completed

Started Oct 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2.1 years

First QC Date

January 11, 2023

Last Update Submit

September 26, 2023

Conditions

Parkinson DiseaseMild Cognitive Impairment

Keywords

Parkinson's Disease-Mild Cognitive Impairment (PD-MCI)DonepezilRandomized Clinical Trial (RCT)

Outcome Measures

Primary Outcomes (2)

  • Parkinson's Disease-Cognitive Rating Scale (PD-CRS)

    Global cognition

    12 months

  • Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS)

    Cognitive functional performance

    12 months

Secondary Outcomes (18)

  • Trail Making Test A (TMT-A)

    12 months

  • TMT-B

    12 months

  • Boston Naming Test

    12 months

  • Free and cued selective reminding test

    12 months

  • Rey-Osterrieth complex figure test (ROCF)

    12 months

  • +13 more secondary outcomes

Study Arms (2)

Donepezil

EXPERIMENTAL
Drug: Donepezil Hydrochloride

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Donepezil HydrochlorideDRUG

Donepezil 10mg once daily

Donepezil
PlaceboDRUG

Matching placebo

Placebo

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson DiseaseCognitive Dysfunction

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2023

First Posted

February 2, 2023

Study Start

October 1, 2023

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share