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Cognitive effects of methylphenidate in patients with Parkinson's disease with mild cognitive impairment.
EU CTIS ID: 2026-525701-12-00
What this study is testing
The objective of the current study is to examine the cognitive effects of a three-month course of methylphenidate (MPD) in Parkinson’s disease (PD) patients with mild cognitive impairment (MCI). This study may contribute to determining whether MPD has beneficial effects on cognition and attention in advanced PD patients who exhibit cognitive impairment. To evaluate these effects, we will use objective electrophysiological measures associated with processing of goal-directed contextual information in working memory, an important executive function that has been shown to be deficient in PD. In addition, we will evaluate the effect of MPD on cognitive function and quality of life in the patients, using neuropsychological tests. This will be the first randomized, double-blind, placebo-controlled study, to specifically evaluate the cognitive effects of MPD in PD patients with MCI.
- 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
- Parkinson's disease patients, 50-80 years old. It will be obligatory for patients to have a good response to levodopa. We will include PD patients with Montreal Cognitive Assessment (MoCA) scores of 20-25, indicating cognitive impairment. No change to PD medications within the month preceding randomization, including starting, stopping, or dosage modifications. Treatment with stable doses of levodopa and cholinesterase inhibitors (ChEIs) is allowable if stable for 3 months before randomization.
You likely can't join if
- Any change in dopaminergic therapy three months prior or during the study. Previous use of methylphenidate. Patients with clinically significant depression, patients who have suffered from hallucinations/delusions/psychosis, severe motor fluctuations and prominent ON dyskinesia, unbalanced arterial hypertension of more than 140/80, uncontrolled hypertension, hepatic or renal failure, uncontrolled malignancy, or untreated glaucoma, women of childbearing potential (screening will include pregnancy test). Hyperthyroidism, symptomatic cardiovascular disease, serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or a family history of sudden death or death related to heart problems. Patients treated with Monoamine Oxidase Inhibitors (MAOIs), other psychotropic medications, or suspected hypersensitivity to methylphenidate or its excipients.
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.