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Multicenter, randomized, double-blind, and placebo-controlled clinical trial to assess the efficacy and safety of donepezil versus placebo in mild cognitive impairment associated with Parkinson's disease.
EU CTIS ID: 2024-510959-35-00
What this study is testing
Assessing the safety and efficacy on cognitive performance of donepezil over 12 months
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age between 50 and 80 years (inclusive).
- Diagnosis of Parkinson's disease based on MDS criteria
- Neuroimaging compatible with Parkinson's disease
- Hoehn and Yahr stage (H&Y) I-III (inclusive).
- Persistent subjective cognitive complaints in the 6 months prior to screening.
- Diagnosis of Parkinson's disease-related mild cognitive impairment (PD-MCI) according to MDS PD-MCI criteria: Level I: MoCA ≤24 and ≥20(46) and Level II: 2/10 neuropsychological tests altered with a cutoff of 1.5 Standard Deviations(47,48).
You likely can't join if
- Criteria for dementia associated with Parkinson's disease
- Insufficient proficiency in Spanish or the local language, illiteracy, sensory impairments (vision, hearing), legal incapacity, or any other mental, physical, or social condition that impedes giving informed consent or completing assessments adequately.
- History of symptomatic orthostatic hypotension.
- Pregnancy, desire for conception, refusal to use appropriate contraceptives during the study period and up to 6 months after, or lactation (see section 9.6).
- Any significant abnormalities in medical history, examination, vital signs, laboratory tests, or ECG that, at the investigator's discretion, contraindicate participation in the study.
- Severe motor complications (moderate to severe motor fluctuations defined as a score >1 on item 42 of Part IV of the MDS UPDRS; or disabling dyskinesias defined as a score >1 on item 36 of Part IV of the MDS UPDRS).
See the full eligibility criteria
Who can join
- Age between 50 and 80 years (inclusive).
- Diagnosis of Parkinson's disease based on MDS criteria
- Neuroimaging compatible with Parkinson's disease
- Hoehn and Yahr stage (H&Y) I-III (inclusive).
- Persistent subjective cognitive complaints in the 6 months prior to screening.
- Diagnosis of Parkinson's disease-related mild cognitive impairment (PD-MCI) according to MDS PD-MCI criteria: Level I: MoCA ≤24 and ≥20(46) and Level II: 2/10 neuropsychological tests altered with a cutoff of 1.5 Standard Deviations(47,48).
- Duration of PD-MCI for at least 3 months prior to screening.
- Stable dopaminergic treatment in the 4 weeks prior to screening.
What rules you out
- Criteria for dementia associated with Parkinson's disease
- Insufficient proficiency in Spanish or the local language, illiteracy, sensory impairments (vision, hearing), legal incapacity, or any other mental, physical, or social condition that impedes giving informed consent or completing assessments adequately.
- History of symptomatic orthostatic hypotension.
- Pregnancy, desire for conception, refusal to use appropriate contraceptives during the study period and up to 6 months after, or lactation (see section 9.6).
- Any significant abnormalities in medical history, examination, vital signs, laboratory tests, or ECG that, at the investigator's discretion, contraindicate participation in the study.
- Severe motor complications (moderate to severe motor fluctuations defined as a score >1 on item 42 of Part IV of the MDS UPDRS; or disabling dyskinesias defined as a score >1 on item 36 of Part IV of the MDS UPDRS).
- History of Deep Brain Stimulation.
- Active psychosis or treatment with antipsychotic medications, major hallucinations, HADS score ≥11, active impulse control disorder, or other severe active behavioral disorders.
- Active treatment with anticholinergics, acetylcholinesterase inhibitors, or other systemic cholinergic enhancers, neuroleptics, potent CYP3A4 or 2D6 inhibitors, enzyme inducers, or drugs prolonging the QTc interval (see section 6.7).
- Hypersensitivity or intolerance to donepezil, piperidine derivatives, lactose, or any of the excipients of the active drug.
- History or impression, at the investigator's discretion, of poor therapeutic compliance.
- Unstable medical or surgical condition, or life expectancy of <1 year.
- Brain condition that may contribute to cognitive decline (history of stroke, brain tumor, neurosurgical intervention, etc.), including the presence of grade III leukoaraiosis on brain neuroimaging.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.