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Cognitive effects of a three‑month methylphenidate course in Parkinson's disease patients with mild cognitive impairment

Registered drug

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What is this trial about?

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

The study focuses on Parkinson's disease and examines the effect of a medication called methylphenidate (MPD) in patients who also have mild cognitive impairment, a condition where thinking and memory are slightly reduced but not severe enough to be called dementia.

The purpose of the study is to determine whether a three‑month course of MPD can improve thinking, attention, and overall quality of life compared with a control pill, which is a placebo. The trial is designed so that neither the participants nor the investigators know who receives the active drug or the control pill, ensuring an unbiased comparison.

Participants will take study tablets daily for three months and attend regular visits where simple brain‑activity recordings (explained as tests that measure the brain’s electrical signals) and mental‑function assessments (explained as tests that evaluate memory, problem‑solving, and attention) are performed, along with questionnaires about daily living and wellbeing.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and baseline assessment
After joining, assignment to either methylphenidate tablets or placebo tablets is made without knowing which one is received.
Baseline measurements of cognitive function, motor function, and quality of life are recorded.
Step 2
Receive study medication
Receive a supply of methylphenidate viatris 10 mg tablets if assigned to active treatment, or matching saccharine tablets if assigned to placebo.
The prescribed dose is 80 mg per day, taken orally as eight 10‑mg tablets divided throughout the day.
The medication is taken every day for a period of three months.
Step 3
Daily medication intake
Take the tablets at the same times each day, usually in the morning and early afternoon, to maintain consistent blood levels.
Do not skip doses; if a dose is missed, follow the instructions provided in the study materials.
Step 4
Monthly follow‑up visits
Attend a clinic visit approximately every four weeks during the three‑month treatment period.
At each visit, the study team records any side effects, checks medication adherence, and repeats selected cognitive and motor tests.
Step 5
End of treatment assessment
After completing three months of medication, a final assessment is performed.
The same electrophysiological and neuropsychological tests used at baseline are repeated to evaluate changes.
Step 6
Study completion
After the final assessment, the study medication is stopped.
All study data are collected for analysis.

Who can join the trial?

7 criteria

Must have Parkinson's disease (a brain condition that affects movement).
Age must be between 50 and 80 years.
Must show a good response to levodopa (a medicine that helps improve movement in Parkinson's disease).
Must have a Montreal Cognitive Assessment (MoCA) score of 20‑25 (a short test that indicates mild thinking problems).
Must not have changed any Parkinson's disease medicines in the month before starting the study (no new medicines, stops, or dose changes).
If taking levodopa or cholinesterase inhibitors (drugs that can help memory), the dose must have stayed the same for at least three months before joining.
Both men and women are eligible to participate.

Who cannot join the trial?

19 criteria

Any change in dopaminergic therapy (medications that increase dopamine) within the last three months or during the study.
Having taken methylphenidate (the study drug) before.
Having a level of depression that is considered clinically significant (meaning it affects daily life).
Experiencing hallucinations (seeing or hearing things that are not there), delusions (strong false beliefs), or psychosis (loss of contact with reality).
Having severe motor fluctuations (big changes in movement ability) and prominent ON dyskinesia (involuntary movements that happen when medication is working).
Having high blood pressure that is unbalanced (higher than 140/80 mmHg) or uncontrolled.
Having serious liver problems (hepatic failure) or kidney problems (renal failure).
Having an active, uncontrolled cancer (malignancy).
Having untreated glaucoma (eye condition that can damage the optic nerve).
Being a woman who could become pregnant (childbearing potential) and not having a negative pregnancy test.
Having an overactive thyroid (hyperthyroidism).
Having symptomatic cardiovascular disease (heart or blood‑vessel problems that cause symptoms).
Having serious structural problems with the heart (structural cardiac abnormalities).
Having cardiomyopathy (disease of the heart muscle).
Having serious heart rhythm problems (heart rhythm abnormalities).
Having a family history of sudden death or death related to heart problems.
Being treated with Monoamine Oxidase Inhibitors (MAOIs) (a type of medication that affects brain chemicals).
Using other psychotropic medications (drugs that affect mood, thoughts, or behavior).
Having a known allergy (hypersensitivity) to methylphenidate or any of its ingredients.

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Investigated drugs

Methylphenidate is the medicine being tested in this study. Participants will take it for three months to see if it can improve thinking, memory, and attention in people with Parkinson’s disease who also have mild problems with thinking. The researchers will measure any changes using special brain tests that look at how well the brain handles information and by giving standard memory and thinking tests. The goal is to find out whether this drug can help patients think more clearly and have a better quality of life.

Methylphenidate Hydrochloride

What is already known about the treatment

Methylphenidate Viatris 10 mg tablets
This medication is taken by mouth as a small tablet that releases methylphenidate hydrochloride, a stimulant that works by blocking the re‑uptake of dopamine and norepinephrine, which raises the levels of these chemicals in the brain. It is an approved treatment for attention‑deficit hyperactivity disorder and narcolepsy, and it is well described in medical literature as a central nervous system stimulant. In this study it is being tested to see if it can improve attention and thinking skills in people with Parkinson’s disease who have mild cognitive problems. The drug belongs to the class of psychostimulants.
saccharine tablets
These are inert tablets that contain only saccharine, a sweet‑tasting substance, and are taken orally to look like the active drug but have no therapeutic effect. They are used as a placebo in clinical trials and are recognized as safe for consumption, but they are not a medicine and have no clinical indication. Because they contain no active ingredient, there is no mechanism of action to describe. They are classified simply as a placebo or inert excipient.

Investigated diseases

Parkinson's disease - Parkinson's disease is a brain disorder that mainly affects movement. It usually begins with a slight tremor or stiffness in one limb and may spread to other parts of the body. Over time, walking, balance, and coordination can become more difficult. Some people also notice changes in thinking, memory, or mood as the condition advances. The symptoms often develop slowly and become more noticeable over months to years.