Overview
Sponsor-declared trial summary
Parkinson's disease
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 patient…
Key facts
- Sponsor
- Universidad Rey Juan Carlos
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01], Phenomena and Processes [G] - Physiological processes [G07]
- Decision date (initial)
- 2026-06-08
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Ministerio de Ciencia, Innovación y Universidades (referencia PID2023-150168NB-I00)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
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.
Conditions and MedDRA coding
Parkinson's disease
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Methylphenidate Three months of methylphenidate
|
Randomised Controlled | Double | [{"id":188244,"code":2,"name":"Investigator"},{"id":188241,"code":5,"name":"Carer"},{"id":188242,"code":4,"name":"Analyst"},{"id":188243,"code":1,"name":"Subject"}] | Methylphenidate: 3 months of methylphenidate |
| 2 | Placebo 3 months of placebo
|
Randomised Controlled | Double | [{"id":188249,"code":1,"name":"Subject"},{"id":188247,"code":4,"name":"Analyst"},{"id":188248,"code":2,"name":"Investigator"},{"id":188246,"code":5,"name":"Carer"}] | Placebo: 3 months of placebo |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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.
Exclusion criteria 1
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- Electrophysiological markers
- Neuropsychological evaluation
- UPDRS II and III
- PDQ-8 (Parkinson’s disease Questionnaire)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Methylphenidate Viatris 10 mg tabletten
PRD11417948 · Product
- Active substance
- Methylphenidate Hydrochloride
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 7200 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- N06BA04 — METHYLPHENIDATE
- Marketing authorisation
- BE489404
- MA holder
- VIATRIS GX
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universidad Rey Juan Carlos
- Sponsor organisation
- Universidad Rey Juan Carlos
- Address
- Calle Del Tulipan Sn
- City
- Madrid
- Postcode
- 28046
- Country
- Spain
Scientific contact point
- Organisation
- Universidad Rey Juan Carlos
- Contact name
- secretariageneral
Public contact point
- Organisation
- Universidad Rey Juan Carlos
- Contact name
- secretariageneral
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Not authorised | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol052026R2 | 1 |
| Protocol (for publication) | ProtocolR2highlightedchanges | 1 |
| Recruitment arrangements (for publication) | Recruitment Arrangements | 1 |
| Subject information and informed consent form (for publication) | MPDInformacionPacienteHUFA1225 | 1 |
| Synopsis of the protocol (for publication) | ProtocolspanishR2 | 1 |
| Synopsis of the protocol (for publication) | ProtocolsynopsisEN | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-11 | Spain | Not acceptable 2026-06-01
|
2026-06-08 |