Artificial Intelligence-based Parkinson's Disease Risk Assessment (AI-PRA) Study

Starting soon

Conditions studied: Parkinson Disease (PD), REM Sleep Behavior Disorder (iRBD), Neurogenic Orthostatic Hypotension, Hyposmia

In brief

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.

Key facts

Study ID

NCT07706829

Run by

Queen Mary University of London

People needed

60

Starts

2026-07-01

Expected to finish

2027-09-30

Last updated by the study team

2026-07-20

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Centre Hospitalier Universitaire de Toulouse — Toulouse, France
• Fundación Iniciativa para las Neurociencias. Hospital Ruber Internacional. — Madrid, Spain
• Queen Mary University of London — London, United Kingdom

Full record on ClinicalTrials.gov

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