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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: erik.stomrud@med.lu.se
• Phone: +46 40 33 10 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.