Phase 2 Parkinson's Disease Trial, Not Yet Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who have been clinically diagnosed with established or probable Parkinson's disease, based on recognised Movement Disorders Society diagnostic criteria.
- People who are aged 40 or older at the time of screening.
- People who score between 17 and 30 on the Montreal Cognitive Assessment (MoCA), a standard test of memory and thinking skills.
- People whose dementia severity rating (measured by the Clinical Dementia Rating scale) is below 1, and whose combined score across six areas of daily functioning is below 4.5, indicating none to very mild symptoms.
- People who have had clinically significant apathy (persistent lack of motivation) for at least four weeks, at a level of frequency and severity that meets specific thresholds on a standardised assessment tool called the Neuropsychiatric Inventory (NPI) (confirm with trial site for exact thresholds).
- People who are able to give informed consent, as confirmed by a capacity assessment tool called the ACED, with a score of 9 or 10 out of 10.
- People who have a primary caregiver who spends more than ten hours a week with them, helps supervise their care, and is able to attend study visits and take part in the study.
- People who, along with their caregiver, have sufficient ability to read and speak English.
- People whose Parkinson's disease medications have not changed — including no new medications started, stopped, or adjusted in dose — in the month before the study begins.
- People who are taking levodopa or cholinesterase inhibitors (medications for thinking and memory) may be eligible if the dose has been stable for at least three months before the study begins; other mental health medications (except antipsychotics) that have been stable for three months may also be considered, subject to approval by the study doctors on a case-by-case basis.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who currently meet the clinical criteria for a Major Depressive Episode.
- People who have had psychotic symptoms — such as those associated with schizophrenia or psychosis linked to mood disorders — in the past two years.
- People who have clinically significant agitation or aggression at a level of frequency and severity that meets specific thresholds on the NPI assessment (confirm with trial site for exact thresholds).
- People who have clinically significant delusions (strongly held false beliefs) at a level of frequency and severity that meets specific thresholds on the NPI assessment (confirm with trial site for exact thresholds).
- People who have clinically significant hallucinations at a level of frequency and severity that meets specific thresholds on the NPI assessment (confirm with trial site for exact thresholds).
- People who have clinically significant impulse control problems, as measured by a specific screening tool (the QUIP).
- People who have had a substance use disorder in the past year, as identified by a standardised screening tool (the DAST-10).
- People who have been taking certain mental health medications within the two weeks before the study begins — antipsychotic medications are expressly not permitted at any time; some other mental health medications may be allowed with study doctor approval if they have been stable for three months (confirm with trial site).
- People for whom the study doctors consider treatment with methylphenidate (the study medication) to be medically unsuitable.
- People who have previously tried methylphenidate for apathy and it did not work.
- People who are taking medications that would be unsafe to use at the same time as methylphenidate, such as monoamine oxidase inhibitors (a type of antidepressant) or tricyclic antidepressants.
- People who currently need acute psychiatric hospital care.
- People who are currently experiencing active thoughts of suicide, as assessed by a standardised rating scale (C-SSRS).
- People with uncontrolled high blood pressure, specifically a diastolic (lower number) reading of 105 mmHg or above over the past three months, or who have not been consistently taking blood pressure medication.
- People with symptomatic coronary artery disease (reduced blood flow to the heart causing symptoms) that the study doctors consider significant at the time of screening.
- People who have had unexplained, unintentional weight loss in the three months before screening, as determined by the study doctors.
- People with significant communication difficulties that would prevent meaningful participation in study assessments.
- People who are currently enrolled in another clinical trial.
- People who have hyperthyroidism, advanced hardening of the arteries, symptomatic cardiovascular disease, serious structural heart problems, cardiomyopathy, serious heart rhythm abnormalities, or a family history of sudden death or heart-related death.
- People who have glaucoma, a tumour of the adrenal gland (pheochromocytoma), or a known or suspected allergy or sensitivity to methylphenidate or any of its ingredients.
- People who have certain brain or blood vessel abnormalities (such as a brain aneurysm, vasculitis, or previous stroke), a history of motor tics or Tourette's syndrome (or a family history of it), a history of seizures or epilepsy, or abnormal brain wave test (EEG) results.
- People whom the study doctors consider to face medical risks or for whom participation would otherwise be inappropriate.
- People who are currently pregnant (methylphenidate is classified as a Category D medication, meaning there is evidence of risk to a developing baby); pregnancy testing will be carried out at screening.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
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Trial details
Primary endpoints
Apathy Evaluation Scale (AES); Clinical Global Impression of Change (CGIC)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.