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Study on Donepezil for Mild Cognitive Impairment in Parkinson's Disease Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called on individuals with who experience mild cognitive impairment. Parkinson's disease is a condition that affects movement and can also impact memory and thinking skills. The medication being tested, donepezil, is usually used to treat Alzheimer's disease, but researchers are exploring its potential benefits for people with Parkinson's disease.

The purpose of the study is to evaluate the safety and effectiveness of donepezil in improving cognitive performance over a period of 12 months. Participants in the study will be randomly assigned to receive either donepezil or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, participants will take the medication orally in the form of a film-coated tablet. The trial will involve regular assessments to monitor cognitive abilities and overall health. These assessments will help determine if donepezil can provide cognitive benefits for those with mild cognitive impairment associated with Parkinson's disease. The study aims to provide valuable insights into potential new treatment options for managing cognitive symptoms in Parkinson's disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age between 50 and 80 years, a diagnosis of Parkinson's disease, and mild cognitive impairment related to Parkinson's disease.

    Neuroimaging and cognitive assessments are conducted to ensure compatibility with the study requirements.

  2. Step 2

    Randomization and initial assessment

    Participants are randomly assigned to receive either the medication donepezil hydrochloride or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication.

    Initial cognitive and functional assessments are conducted using scales such as the Parkinson's Disease-Cognitive Rating Scale (PD-CRS) and the Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS).

  3. Step 3

    Medication administration

    Participants take the assigned medication orally in the form of a film-coated tablet called ARICEPT 10mg once daily.

    The duration of medication administration is 12 months, during which participants continue their regular dopaminergic treatment.

  4. Step 4

    Ongoing assessments

    Throughout the 12-month period, participants undergo regular assessments to monitor cognitive performance and overall health.

    Secondary assessments include tests such as the Trail Making Test, Digit Span, and various fluency and memory tests, as well as evaluations of mood and daily functioning.

  5. Step 5

    Final assessment and conclusion

    At the end of the 12-month period, a final assessment is conducted to evaluate the efficacy and safety of the medication.

    The study concludes with a comprehensive analysis of the collected data to determine the impact of donepezil on cognitive performance in participants with mild cognitive impairment associated with Parkinson's disease.

Who can join the trial?

8 criteria

  • Age between 50 and 80 years, including both ages.
  • Have a diagnosis of Parkinson's disease based on specific criteria set by the Movement Disorder Society (MDS).
  • Have brain imaging results that are consistent with Parkinson's disease.
  • Be in stages I to III of the Hoehn and Yahr scale, which is a way to describe how advanced Parkinson's disease is.
  • Have ongoing personal concerns about memory or thinking problems for at least 6 months before the study starts.
  • Have a diagnosis of mild cognitive impairment related to Parkinson's disease, which means having some memory or thinking issues but not severe enough to be dementia. This is determined by specific tests, including a MoCA score between 20 and 24 and changes in 2 out of 10 neuropsychological tests.
  • Have had mild cognitive impairment related to Parkinson's disease for at least 3 months before the study starts.
  • Have been on a stable treatment for Parkinson's disease using medications that increase dopamine levels for at least 4 weeks before the study starts.

Who cannot join the trial?

4 criteria

  • Individuals who do not have a diagnosis of Parkinson's disease cannot participate.
  • Participants must be within the specified age range, which typically includes adults and older adults.
  • Both males and females are eligible, so gender is not a reason for exclusion.
  • Individuals who are considered part of a vulnerable population, such as those unable to give informed consent, are not included.
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Investigated drugs

Donepezil is a medication used in this clinical trial to evaluate its effectiveness and safety in improving cognitive performance in individuals with mild cognitive impairment associated with Parkinson's disease. It works by increasing the levels of a certain natural substance in the brain, which may help improve memory, awareness, and the ability to function.

What is already known about the treatment

Donepezil – Donepezil is administered orally, typically in tablet form, and is used to improve cognitive function. It is currently being studied in clinical trials for its effectiveness in treating mild cognitive impairment associated with Parkinson's disease. The medication works by increasing levels of acetylcholine, a neurotransmitter, in the brain, which helps improve memory and cognition. Donepezil is classified as a cholinesterase inhibitor and is commonly used in the treatment of Alzheimer's disease, with ongoing research exploring its potential benefits for other cognitive disorders.

Investigated diseases

Parkinson's disease – Parkinson's disease is a progressive neurological disorder that primarily affects movement. It is characterized by tremors, stiffness, and difficulty with balance and coordination. As the disease progresses, individuals may experience slowness of movement and changes in speech and writing. Non-motor symptoms, such as cognitive impairment, mood disorders, and sleep disturbances, can also occur. The progression of symptoms varies among individuals, and the disease typically advances over several years.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510959-35-00Protocol codeIIBPS-DON-2022-43Estimated enrolment120 patientsSponsorFundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

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