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

Primary Purpose

Parkinson Disease, Mild Cognitive Impairment

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Donepezil Hydrochloride
Placebo
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's Disease-Mild Cognitive Impairment (PD-MCI), Donepezil, Randomized Clinical Trial (RCT)

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Donepezil

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Parkinson's Disease-Cognitive Rating Scale (PD-CRS)
    Global cognition
    Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS)
    Cognitive functional performance

    Secondary Outcome Measures

    Trail Making Test A (TMT-A)
    Attention
    TMT-B
    Executive functions
    Boston Naming Test
    Language
    Free and cued selective reminding test
    Memory
    Rey-Osterrieth complex figure test (ROCF)
    Visuospatial
    Hospital Anxiety and Depression Scale
    Depression and Anxiety
    Starkstein Apathy scale
    Apathy
    Neuropsychiatric Inventory
    Hallucinations
    Schwab & England scale
    Quality of life
    Clinical Global Impressions-Severity of illness
    Subjective clinical change
    CGI-Global improvement
    Subjective clinical change
    Patient Global Impression of Change
    Subjective clinical change
    8-item Parkinson's Disease Questionnaire
    Quality of life
    Judgment of Line Orientation
    Visuspatial
    recall of ROCF
    Memory
    Category fluency
    Language
    Phonemic Fluency
    Executive functions
    direct Digit Span
    Attention

    Full Information

    First Posted
    January 11, 2023
    Last Updated
    September 26, 2023
    Sponsor
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05709301
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2025 (Anticipated)
    Study Completion Date
    November 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease, Mild Cognitive Impairment
    Keywords
    Parkinson's Disease-Mild Cognitive Impairment (PD-MCI), Donepezil, Randomized Clinical Trial (RCT)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Donepezil
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Donepezil Hydrochloride
    Intervention Description
    Donepezil 10mg once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching placebo
    Primary Outcome Measure Information:
    Title
    Parkinson's Disease-Cognitive Rating Scale (PD-CRS)
    Description
    Global cognition
    Time Frame
    12 months
    Title
    Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS)
    Description
    Cognitive functional performance
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Trail Making Test A (TMT-A)
    Description
    Attention
    Time Frame
    12 months
    Title
    TMT-B
    Description
    Executive functions
    Time Frame
    12 months
    Title
    Boston Naming Test
    Description
    Language
    Time Frame
    12 months
    Title
    Free and cued selective reminding test
    Description
    Memory
    Time Frame
    12 months
    Title
    Rey-Osterrieth complex figure test (ROCF)
    Description
    Visuospatial
    Time Frame
    12 months
    Title
    Hospital Anxiety and Depression Scale
    Description
    Depression and Anxiety
    Time Frame
    12 months
    Title
    Starkstein Apathy scale
    Description
    Apathy
    Time Frame
    12 months
    Title
    Neuropsychiatric Inventory
    Description
    Hallucinations
    Time Frame
    12 months
    Title
    Schwab & England scale
    Description
    Quality of life
    Time Frame
    12 months
    Title
    Clinical Global Impressions-Severity of illness
    Description
    Subjective clinical change
    Time Frame
    12 months
    Title
    CGI-Global improvement
    Description
    Subjective clinical change
    Time Frame
    12 months
    Title
    Patient Global Impression of Change
    Description
    Subjective clinical change
    Time Frame
    12 months
    Title
    8-item Parkinson's Disease Questionnaire
    Description
    Quality of life
    Time Frame
    12 months
    Title
    Judgment of Line Orientation
    Description
    Visuspatial
    Time Frame
    12 months
    Title
    recall of ROCF
    Description
    Memory
    Time Frame
    12 months
    Title
    Category fluency
    Description
    Language
    Time Frame
    12 months
    Title
    Phonemic Fluency
    Description
    Executive functions
    Time Frame
    12 months
    Title
    direct Digit Span
    Description
    Attention
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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