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Using a smartwatch and phone app to estimate Parkinson's disease risk

Tests an artificial intelligence model that estimates Parkinson's disease risk in people over 50.

Plain-language title generated from the registry record
Registry title: Artificial Intelligence-based Parkinson's Disease Risk Assessment (AI-PRA) Study

Key facts

Where
Madrid, SpainSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 50 or older who do not have Parkinson's disease but show an early warning sign of it. They wear a smartwatch and use a phone app.

Age
50 years or older
Sex
All sexes can join
Disease stage
No diagnosis of Parkinson's disease. At least one risk sign is needed: REM sleep behaviour disorder confirmed by a sleep test, neurogenic orthostatic hypotension (a drop in blood pressure on standing with a blunted heart rate response), or a clearly reduced sense of smell.
Earlier treatment
Cannot be taking Parkinson's medicines such as levodopa, dopamine agonists, MAO-B inhibitors or amantadine. Neuroleptics, reserpine or metoclopramide must be stopped at least 6 months before screening.
Biomarker or test result
Reduced sense of smell: UPSIT score at or below the 15th percentile for age and sex. Low blood pressure on standing: a drop of 20/10mmHg or more within 3 minutes, with heart rate change per blood pressure drop below 0.5 bpm/mmHg.

Main reasons for not taking part

  • Diagnosed Parkinson's disease
  • Taking Parkinson's medicines
  • Dementia
  • Pregnancy
  • Taking part in another interventional study

Read by machine on 9 November 2026.

Where in Spain

  • Fundación Iniciativa para las Neurociencias. Hospital Ruber Internacional.Madrid, SpainNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Queen Mary University of London
Trial code
NCT07706829
Record updated
2 October 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: 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; 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; 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.

ClinicalTrials.gov NCT07706829