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

NCT07706829 | Not Yet Recruiting

• 1 other identifier: 370634
• Study Type: observational
• Target: 60
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Neurogenic Orthostatic Hypotension; Hyposmia; Parkinson Disease (PD); REM Sleep Behavior Disorder (iRBD)

Keywords

prodromal Parkinson's disease; neurogenic orthostatic hypotension; REM sleep behaviour disorder; hyposmia; Digital biomarkers; AI-PROGNOSIS; Smartwatch; Wearable electronic devices

Outcome Measures

Primary Outcomes (1)

• Classification performance of the PD risk artificial intelligence-based model

  Classification performance of the model in predicting dopaminergic degeneration defined as a binary outcome: a participant will be considered to have dopaminergic degeneration if putamen specific binding ratio (SBR) on the most affected side is below 2 standard deviations of age-matched normative data or shows abnormal visual inspection by a qualified nuclear medicine specialist on dopamine transporter SPECT imaging.

  From enrolment to 6 months

Secondary Outcomes (1)

• Usability of study digital environment (mAI-Health phone app)

  At 6 month visit

Study Arms (1)

Cohort of people at risk of Parkinson's disease

People at risk of PD defined by the presence of either polysomnography-confirmed REM sleep behaviour disorder, neurogenic orthostatic hypotension or objective hyposmia documented with smell test.

Device: Smartwatch and phone app

Interventions

Smartwatch and phone app DEVICE

Wearing a smartwatch and using a mobile phone application for 6 months in order to provide digital biomarker data and additional self reported clinical information.

Cohort of people at risk of Parkinson's disease

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People at risk of PD due to the presence of clinical markers associated with prodromal PD including one of the following: 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.

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.

Sponsors & Collaborators

• Queen Mary University of London: lead
• Hospital Ruber Internacional: collaborator
• University Hospital, Toulouse: collaborator
• Aristotle University Of Thessaloniki: collaborator

Study Sites (3)

Centre Hospitalier Universitaire de Toulouse

Toulouse, France

Location

Fundación Iniciativa para las Neurociencias. Hospital Ruber Internacional.

Madrid, Spain

Location

Queen Mary University of London

London, United Kingdom

Location

Related Publications (3)

• Hastings A, Cullinane P, Wrigley S, Revesz T, Morris HR, Dickson JC, Jaunmuktane Z, Warner TT, De Pablo-Fernandez E. Neuropathologic Validation and Diagnostic Accuracy of Presynaptic Dopaminergic Imaging in the Diagnosis of Parkinsonism. Neurology. 2024 Jun 11;102(11):e209453. doi: 10.1212/WNL.0000000000209453. Epub 2024 May 17.

  PMID: 38759132 BACKGROUND

• Heinzel S, Berg D, Gasser T, Chen H, Yao C, Postuma RB; MDS Task Force on the Definition of Parkinson's Disease. Update of the MDS research criteria for prodromal Parkinson's disease. Mov Disord. 2019 Oct;34(10):1464-1470. doi: 10.1002/mds.27802. Epub 2019 Aug 14.

  PMID: 31412427 BACKGROUND

• Berg D, Postuma RB, Adler CH, Bloem BR, Chan P, Dubois B, Gasser T, Goetz CG, Halliday G, Joseph L, Lang AE, Liepelt-Scarfone I, Litvan I, Marek K, Obeso J, Oertel W, Olanow CW, Poewe W, Stern M, Deuschl G. MDS research criteria for prodromal Parkinson's disease. Mov Disord. 2015 Oct;30(12):1600-11. doi: 10.1002/mds.26431.

  PMID: 26474317 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected at baseline for DNA analysis (polygenic risk score for Parkinson's disease)

MeSH Terms

Conditions

Parkinson Disease; REM Sleep Behavior Disorder; Anosmia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Mental Disorders; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eduardo de Pablo Fernández

CONTACT

+44 20 7882 8693; e.depablofernandez@qmul.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: To be determined (after completion of the study and publication of the main study results).
• Access Criteria: Qualified investigators will be able to access fully anonymised dataset according to ethical permissions through public repository.

Locations

FR (1); ES (1); GB (1)