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Recruiting NCT06629207

Artificial Intelligence in Molecular Imaging: Predicting Parkinson's Risk in REM Sleep Behavior Disorder

No phase Interventional Parkinson Disease REM Sleep Behavior Disorder Dementia, Lewy Body

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PET/CT with 18-FDG, SPECT : 123 I-FP-CIT (DATSCAN), MRI.
Who it may be relevant to
Registry conditions: Parkinson Disease, REM Sleep Behavior Disorder, Dementia, Lewy Body. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Artificial Intelligence on Molecular Imaging to Predict the Risks of Parkinson's Disease for Patients With Rapid Eye Movement Sleep Behavior Disorder

Overview

The study aims to systematically document the course of REM sleep behavior disorder (RBD) and investigate possible clinical and imaging biomarkers for disease progression and conversion risk to Parkinson's disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA). The study will use artificial intelligence to analyze imaging and develop a reliable method to predict and stratify patients approaching conversion to overt a-synucleinopathy. Participants will be clinically evaluated and 2 imaging procedures will be done.

Interventions

  • Device PET/CT with 18-FDG
    FDG-PET scans will be acquired in a Siemens Biograph Vision Quadra PET/CT (Siemens, Germany) at 30-minute post-injection of approximately 80 MBq 18F-FDG. The duration of the acquisition is 20 minutes. The PET images will be reconstructed with the vendor's time of flight (TOF) point-spread-function (PSF) algorithm, following corrections for randoms, scatter, and decay. Attenuation correction will be performed first using low-dose CT.
  • Device SPECT : 123 I-FP-CIT (DATSCAN)
    DaT-Scans will be acquired in a GE Discovery NM/CT 670 Pro™. After injection of approximately 110 MBq 123I-FP-CIT, images will be acquired within 4 h post-injection. The duration of the acquisition is 35 minutes.
  • Device MRI
    MRI examination to exclude structural brain anomalies.

Primary outcome measures

  • Assessment of Deep Learning Model Accuracy in Predicting Neurodegenerative Conversion in isolated REM sleep behavior disorder (iRBD) through Early Biomarker Detection [Time frame: From enrollment to end of follow-up period, expected to be 48 months]
Secondary outcome measures (2)
  • Comparison of the Estimated versus Observed Annual Conversion Risk of Isolated Rapid Eye Movement Behavior Disorder (iRBD) to Neurodegenerative Disorders [Time frame: From enrollment to end of follow-up period, expected to be 48 months]
  • Evaluation of Deep Learning Model Accuracy in Predicting Conversion of Isolated REM Sleep Behavior Disorder (iRBD) to Parkinson's Disease [Time frame: From enrollment to end of follow-up period, expected to be 48 months]

Eligibility criteria

Inclusion criteria

  • Confirmed clinical iRBD diagnosis by movement disorder specialists according to the International Classification of Sleep Disorders
  • Written informed consent

Exclusion criteria

  • Known diagnosis of PD or other neurodegenerative disorder
  • Unequivocal signs of parkinsonism on examination
  • Narcolepsy or other known causes of RBD
  • Moderate to severe obstructive sleep apnea
  • Abnormal neurological or MRI examination

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Switzerland · 1 center
  • Inselspital, University Clinic for Nuclear Medicine — Bern

Identifiers

NCT: NCT06629207 · 2023-00816

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗