Swedish BioFINDER Sleep program for early Parkinson's disease and REM sleep behavior disorder

BioFINDER-Sleep: Idiopathic REM-sleep Behavior Disorder & Early Parkinson's Disease

This project will test whether sleep studies, brain and heart imaging, and fluid biomarkers can identify synuclein pathology and help predict progression in people with early Parkinson's disease or idiopathic REM sleep behavior disorder.

Quick facts

• Study type: Observational
• Enrollment: 650 (estimated)
• Ages: 50 Years to 100 Years
• Sex: All
• Sponsor: Skane University Hospital (other)
• Locations: 1 site (Malmö)
• Trial ID: NCT07533799 on ClinicalTrials.gov

What this trial studies

The project enrolls people with newly diagnosed or early Parkinson's disease and people with polysomnography-confirmed idiopathic REM sleep behavior disorder for longitudinal follow-up. Participants undergo overnight polysomnography, multimodal MRI, dopamine transporter PET, cardiac [123I] MIBG scintigraphy, skin and CSF sampling for α-synuclein seed amplification assays, and blood biomarker collection. Motor function will be measured with instrumented gait systems and clinical scales, and all measures are repeated over time to track changes. The combined imaging and biochemical approach aims to map relationships between synuclein pathology, co-pathologies like Alzheimer's changes, and clinical progression.

Who should consider this trial

Good fit: Ideal candidates are Swedish-speaking adults aged about 50–100 with either polysomnography-verified idiopathic RBD or early, de novo (or ≤3 years treated) Parkinson's disease who can give informed consent and undergo imaging and sample collection.

Not a fit: Patients with advanced Parkinson's disease, those unable to undergo PET/MRI/CSF sampling or polysomnography, or non-Swedish speakers who cannot complete study procedures are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the project could enable earlier and more accurate identification of synuclein-related disease and better prediction of who will progress to Parkinsonian disorders.

How similar studies have performed: Prior work shows that imaging and α-synuclein seed amplification assays can detect pathology, but combining these modalities longitudinally in early PD and iRBD to predict progression is relatively novel.

Eligibility criteria

Inclusion Criteria:

Idiopathic RBD:

* Polysomnography verified RBD according to AASM criteria.
* Does not fulfill diagnostic criteria for idiopathic Parkinson´s disease.
* Age range 50-100. Women who are \<55 years of age will be required to take a pregnancy test before participation in the PET and scintigraphy part of the study if not post-menopausal.
* Ability to give informed consent.
* Speaks and understands Swedish to the extent that an interpreter is not necessary for the patient to fully understand the study information and cognitive tests.

Early Parkinson´s disease:

* Fulfills the diagnostic criteria for idiopathic Parkinson´s disease.
* The PD patients will be de novo (yet without any PD treatment) or with treatment for a maximum of 3 years.
* Age range 50-100. Women who are \<55 years of age will be required to take a pregnancy test before participation in the PET and scintigraphy part of the study if not post-menopausal.
* Ability to give informed consent.
* Speaks Swedish fluently as stated above. Healthy Controls
* Age range 50-100. Women who are \<55 years of age will be required to take a pregnancy test before participation in the PET and scintigraphy part of the study if not post-menopausal.
* No diagnosis of PD or another significant neurological disorder.
* No diagnosis of RBD.
* Ability to give informed consent.
* Speaks Swedish fluently as stated above.

Exclusion Criteria:

For all groups:

* Past history of severe or repeated concussive head injury or stroke or any significant systemic disease or unstable medical condition.
* History of severe and unstable depression, schizophrenia, schizoaffective disorder or bipolar disorder.
* Significant white matter microvascular disease.
* Contraindication to MRI and PET.

Exclusion criteria specific for early Parkinson´s disease:

* Normal dopamine transporter (\[18F\]FE-PE2I) scan.

Where this trial is running

Malmö

• Skane University Hospital — Malmö, Sweden (RECRUITING)

Study contacts

• Principal investigator: Erik Stomrud, MD, PhD — Skane University Hospital and Lund University
• Study coordinator: Erik Stomrud, MD, PhD

Conditions: Parkinson´s Disease, REM Sleep Behavior Disorder, Lewy Body Disease, Synucleinopathy, Synucleinopathies, Early diagnosis, CSF, Plasma