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

Not Yet RecruitingN/A

Sponsor: Queen Mary University of London

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

Interventions: Smartwatch and phone app

Countries: France, Spain, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 50 years.
2. At least one of the following clinical markers for PD risk:

1. REM sleep behaviour disorder (RBD) confirmed with polysomnography.
2. 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).
3. Objective hyposmia defined as University of Pennsylvania Smell Identification Test (UPSIT) score ≤ 15th percentile for age and sex.
3. Able and willing to give informed written consent.
4. 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.

Exclusion Criteria:

1. Clinical diagnosis of Parkinson's disease (PD) according to MDS clinical diagnostic criteria.
2. 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).
3. Dementia defined as deterioration of cognitive function severe enough to impair functioning on daily activities.
4. 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.
5. Pregnant women.
6. Concomitant participation in interventional studies.
7. Unwilling or unable to give informed written consent.
8. Vulnerable individuals as defined by the HRA.
9. Inability to use the smartwatch and/or the mAI-Health app for the purpose of the study as judged by the investigator.

Locations (3)

Toulouse, France
Madrid, Spain
London, United Kingdom