Methylphenidate for Cognitive Improvement in Parkinson’s Disease Patients with Mild Cognitive Impairment: A Randomized Controlled Trial

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What is this study about?

The study focuses on individuals with Parkinson’s disease who also have mild cognitive impairment. The medication being tested is methylphenidate (code name MPD) taken as tablets, and a matching placebo tablet will be used for comparison.

The purpose of the study is to determine whether MPD can improve thinking skills and attention in this population. Participants will receive the assigned medication or placebo for approximately three months, with regular check‑ins to monitor safety and collect information.

During the trial, researchers will record brain activity using simple electrical measurements known as electrophysiological markers and will conduct short memory and problem‑solving tests called neuropsychological evaluation. Standard questionnaires such as the UPDRS (a scale that rates motor function and daily activities) and the PDQ-8 (a short survey about quality of life) will also be completed to assess any changes.

1 baseline assessment

after joining the study, attend an initial visit at the clinic. during this visit, provide information about your health history and current medications. complete baseline questionnaires that measure quality of life and daily functioning. undergo initial neuropsychological tests that assess memory, attention, and executive function. a short brain activity recording (electrophysiological measurement) is performed to establish a reference point.

2 randomization and medication assignment

based on a computerized process, you will be assigned to receive either methylphenidate or a matching placebo tablet. the assignment is double‑blind, meaning neither you nor the study staff will know which product you receive.

3 start of medication period

begin taking the study medication daily for a total of three months. the prescribed dose is 80 mg of methylphenidate (or equivalent placebo) taken by mouth. the dose is divided into tablets that contain 10 mg each, so eight tablets are taken each day as instructed by the study pharmacist. the tablets are taken at the same times each day, usually in the morning and early afternoon, to maintain consistent drug levels.

4 regular safety and compliance visits

visit the clinic approximately once every four weeks during the three‑month medication period. at each visit, report any side effects, receive a new supply of tablets, and have vital signs checked. the study staff will confirm that the medication is being taken as directed.

5 first follow‑up assessment (month 1)

after four weeks of medication, complete a set of neuropsychological tests similar to the baseline assessment. answer the pdq‑8 questionnaire, which asks about the impact of parkinson’s disease on daily life. these data are compared with the baseline results to evaluate early changes.

6 second follow‑up assessment (month 2)

after eight weeks, undergo another electrophysiological recording to measure brain activity related to working memory. repeat the neuropsychological tests and the pdq‑8 questionnaire. the clinical rating scales updrs ii and iii are completed by the examiner to assess motor symptoms.

7 final assessment (month 3)

at the end of the three‑month treatment, stop taking the study medication. attend a final clinic visit for comprehensive evaluation. repeat all previous assessments: electrophysiological measurement, neuropsychological testing, updrs ii and iii rating, and the pdq‑8 questionnaire. the results are used to determine the overall effect of the medication on cognition and quality of life.

8 study completion

after the final visit, no further study procedures are required. data collected during the trial will be analyzed to answer the research question about the cognitive effects of methylphenidate in parkinson’s disease patients with mild cognitive impairment.

Who Can Join the Study?

Be a person with Parkinson’s disease who is between 50 and 80 years old.
Show a good response to the medication levodopa, which is used to control Parkinson’s symptoms.
Score between 20 and 25 on the Montreal Cognitive Assessment (MoCA) test, a short exam that checks thinking and memory abilities and indicates mild cognitive impairment.
Not have any changes to Parkinson’s medicines (starting, stopping, or dose adjustments) in the month before being assigned to a treatment group (randomization).
If taking levodopa or cholinesterase inhibitors (drugs that can help memory), the doses must have stayed the same for at least three months before assignment.
Both men and women are eligible to join the study.

Who Cannot Join the Study?

Any change in medicines that increase dopamine (dopaminergic therapy) within three months before the study or during the study.
Having used the study drug methylphenidate before.
Having clinically significant depression (persistent low mood that interferes with daily life).
Having experienced hallucinations (seeing or hearing things that are not real), delusions (strong false beliefs), or psychosis (loss of touch with reality).
Having severe changes in movement symptoms or strong involuntary movements when medication is working (severe motor fluctuations and prominent ON dyskinesia).
Having high blood pressure that is not under control, especially above 140/80 mmHg (unbalanced arterial hypertension or uncontrolled hypertension).
Having failure of the liver (hepatic failure) or kidneys (renal failure).
Having an active, uncontrolled form of cancer (uncontrolled malignancy).
Having untreated glaucoma (an eye condition that can damage the optic nerve).
Being a woman who could become pregnant (women of childbearing potential), as pregnancy testing is required.
Having an overactive thyroid gland (hyperthyroidism).
Having serious heart problems, such as symptoms of heart disease (symptomatic cardiovascular disease), major structural heart defects (serious structural cardiac abnormalities), weakened heart muscle (cardiomyopathy), serious irregular heartbeats (heart rhythm abnormalities), or a family history of sudden death related to heart problems.
Taking medicines that inhibit the enzyme monoamine oxidase (Monoamine Oxidase Inhibitors (MAOIs)) or other psychiatric medications (psychotropic medications).
Being allergic or overly sensitive (hypersensitivity) to methylphenidate or any of its inactive ingredients.

Where you can join this trial?

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Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.06.2026

Trial locations

Investigated drugs:

Methylphenidate Hydrochloride

Methylphenidate is a medication taken by mouth in tablet form. In this study, it is given to people with Parkinson’s disease who also have mild problems with thinking and memory. The researchers want to see if taking methylphenidate for three months can help improve the patients’ attention, memory, and overall thinking abilities. They will measure these effects using special brain tests that look at how well the brain handles information that needs to be remembered and used, as well as standard tests that assess daily thinking skills and quality of life.

Parkinson’s disease – It is a neurological condition that mainly affects movement. It starts with subtle signs such as slight tremor, stiffness, or slower movements. Over time these symptoms may become more noticeable and can spread to other parts of the body. The disease also often leads to changes in balance and coordination. Cognitive functions such as memory and attention can gradually become less sharp as the condition advances.

Trial ID:

2026-525701-12-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Methylphenidate for Cognitive Improvement in Parkinson’s Disease Patients with Mild Cognitive Impairment: A Randomized Controlled Trial

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?