Artificial Intelligence in Molecular Imaging: Predicting Parkinson's Risk in REM Sleep Behavior Disorder (NUK-RBD)

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: REM Sleep Behavior Disorder; Parkinson Disease; Dementia, Lewy Body

Treatments: Device: PET/CT with 18-FDG; Device: SPECT : 123 I-FP-CIT (DATSCAN); Device: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT06629207

2023-00816

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Known diagnosis of PD or other neurodegenerative disorder
2. Unequivocal signs of parkinsonism on examination
3. Narcolepsy or other known causes of RBD
4. Moderate to severe obstructive sleep apnea
5. Abnormal neurological or MRI examination

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

NUK-RB Study

Experimental group

Treatment:

Device: MRI

Device: SPECT : 123 I-FP-CIT (DATSCAN)

Device: PET/CT with 18-FDG

Sponsor of this trial

Lead Sponsor

Insel Gruppe AG, University Hospital Bern