Study evaluating the efficacy and safety of donepezil versus placebo in mild cognitive impairment associated with Parkinson's disease

Phase 1

• Conditions: Parkinson's disease; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2022-001751-17-ES
• Lead Sponsor: Institut de Recerca Hospital de la Santa Creu i Sant Pau - IIB Sant Pau

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-31
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

- 50-80 years (included)
- Diagnosis of PD based on MDS criteria(45)
- Neuroimaging compatible with PD
- Hoehn and Yahr Stadium (H&Y) I-III (included)
- Persistent subjective cognitive complaints in the 6 months prior to Screening
- Diagnosis of MCI-EP by MDS MCI-EP criteria:
- Duration of DCL-EP of at least 3 months prior to Screening
- Stable dopaminergic treatment in the 4 weeks prior to Screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- Criteria for dementia associated with PD(49)
- Severe motor complications (moderate-severe motor fluctuations defined as a score >1 on MDS UPDRS Part IV item 42; or disabling dyskinesias defined as a score >1 on MDS UPDRS Part IV item 36)
- History of Deep Brain Stimulation
- Active or antipsychotic psychosis, major hallucinations, HADS score =11, active impulse control disorder, or other active severe behavioral disorders
- Active treatment with anticholinergics, acetylcholinesterase inhibitors or other systemic cholinergic enhancers, or neuroleptics
- Hypersensitivity or intolerance to donepezil, to piperidine derivatives, to lactose or to any of the excipients of the active drug

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified