Artificial Intelligence-based Parkinson's Disease Risk Assessment (AI-PRA) Study
France, Spain, United Kingdom60 participantsStarted 2026-07-01
Plain-language summary
The study aims to provide initial proof-of-concept validation data of an artificial intelligence-based model to estimate individual Parkinson's disease risk using demographic, clinical, genetic information and digital biomarker data collected via a smartwatch and a mobile application.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 50 years.
. At least one of the following clinical markers for PD risk:
. REM sleep behaviour disorder (RBD) confirmed with polysomnography.
. Neurogenic orthostatic hypotension (nOH) defined as a drop in systolic / diastolic blood pressure ≥ 20/10mmHg within 3 minutes of active standing or tilt-table test, and with a blunted heart rate response (ΔHeart rate/ΔSBP ratio \< 0.5 bpm/mmHg).
. Objective hyposmia defined as University of Pennsylvania Smell Identification Test (UPSIT) score ≤ 15th percentile for age and sex.
. Able and willing to give informed written consent.
. Use of compatible smartphone (mobile operating system Android version 11 or newer). A smartwatch will be provided to each participant for the duration of the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is focused on building an AI model to classify PD risk — it's not yet recruiting and isn't testing a treatment, so would participating actually change how my condition is monitored or managed, or would it mainly contribute to future research?
2Since this study involves conditions like REM sleep behavior disorder, loss of smell, and neurogenic orthostatic hypotension as markers of Parkinson's risk, do I have any of these features that might make my situation relevant to this kind of research?
3Because this is listed as Phase N/A and seems to be an observational or diagnostic accuracy study, what would participation actually involve for me — things like tests, visits, or data collection — and how demanding would that be on my day-to-day life?
4Given that this trial isn't recruiting yet, are there other currently active studies or standard clinical evaluations that could assess my Parkinson's risk in the meantime, rather than waiting for this one to open?
5If the AI model being tested in this study eventually proves useful, how might that change the way doctors like you screen or counsel people who have early warning signs like mine?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Classification performance of the PD risk artificial intelligence-based model
. Clinical diagnosis of Parkinson's disease (PD) according to MDS clinical diagnostic criteria.
. Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or another PD medication, except for low-dose treatment of restless leg syndrome (with permission of investigator).
. Dementia defined as deterioration of cognitive function severe enough to impair functioning on daily activities.
. Active treatment with neuroleptics, reserpine or metoclopramide (these drugs should be discontinued for at least 6 months before screening visit) due to their interference with dopamine transporter SPECT imaging acquisition and interpretation.
. Pregnant women.
. Concomitant participation in interventional studies.
. Unwilling or unable to give informed written consent.