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

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05709301
Collaborator
(none)
120
Enrollment
2
Arms
25
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Donepezil Hydrochloride
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Multicenter, Randomized, Double-blinded, Placebo-controlled Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Donepezil

Drug: Donepezil Hydrochloride
Donepezil 10mg once daily
Placebo Comparator: Placebo

Drug: Placebo
Matching placebo

Outcome Measures

Primary Outcome Measures

  1. Parkinson's Disease-Cognitive Rating Scale (PD-CRS) [12 months]

    Global cognition

  2. Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS) [12 months]

    Cognitive functional performance

Secondary Outcome Measures

  1. Trail Making Test A (TMT-A) [12 months]

    Attention

  2. TMT-B [12 months]

    Executive functions

  3. Boston Naming Test [12 months]

    Language

  4. Free and cued selective reminding test [12 months]

    Memory

  5. Rey-Osterrieth complex figure test (ROCF) [12 months]

    Visuospatial

  6. Hospital Anxiety and Depression Scale [12 months]

    Depression and Anxiety

  7. Starkstein Apathy scale [12 months]

    Apathy

  8. Neuropsychiatric Inventory [12 months]

    Hallucinations

  9. Schwab & England scale [12 months]

    Quality of life

  10. Clinical Global Impressions-Severity of illness [12 months]

    Subjective clinical change

  11. CGI-Global improvement [12 months]

    Subjective clinical change

  12. Patient Global Impression of Change [12 months]

    Subjective clinical change

  13. 8-item Parkinson's Disease Questionnaire [12 months]

    Quality of life

  14. Judgment of Line Orientation [12 months]

    Visuspatial

  15. recall of ROCF [12 months]

    Memory

  16. Category fluency [12 months]

    Language

  17. Phonemic Fluency [12 months]

    Executive functions

  18. direct Digit Span [12 months]

    Attention

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT05709301
Other Study ID Numbers:
  • IIBSP-DON-2022-43
First Posted:
Feb 2, 2023
Last Update Posted:
Feb 2, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Parkinson's Disease-Mild Cognitive Impairment (PD-MCI)
Donepezil
Randomized Clinical Trial (RCT)
Additional relevant MeSH terms:
Parkinson Disease
Cognitive Dysfunction
Donepezil

Study Results

No Results Posted as of Feb 2, 2023