NCT07706829Not yet recruiting
Artificial Intelligence-based Parkinson's Disease Risk Assessment (AI-PRA) Study
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 1 Jul 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Queen Mary University of London
- Diseases
- Parkinson disease
- NCT number
- NCT07706829
What you commit to
- Study type: Observational
- Planned participants: 60
- From 1 Oct 2026 to the primary completion date, 30 Sept 2027
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- 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.
- Concomitant participation in interventional studies.
Other illness
- Clinical diagnosis of Parkinson's disease (PD) according to MDS clinical diagnostic criteria.
- Dementia defined as deterioration of cognitive function severe enough to impair functioning on daily activities.
Other
- Pregnant women.
- Unwilling or unable to give informed written consent.
- Vulnerable individuals as defined by the HRA.
- Inability to use the smartwatch and/or the mAI-Health app for the purpose of the study as judged by the investigator.
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundación Iniciativa para las Neurociencias. Hospital Ruber Internacional. Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Queen Mary University of London Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.