Actively Recruiting
The Swedish BioFINDER Sleep Study
Led by Skane University Hospital · Updated on 2026-04-16
650
Participants Needed
1
Research Sites
608 weeks
Total Duration
On this page
Sponsors
S
Skane University Hospital
Lead Sponsor
L
Lund University
Collaborating Sponsor
AI-Summary
What this Trial Is About
BioFINDER-Sleep study was established in 2021 and will include patients with early Parkinson´s disease (PD) and persons with iRBD to provide essential insights into the underlying mechanisms of the progressive neurodegenerative processes in central and peripheral nervous systems. Briefly polysomnography will be used to establish the presence of RBD in both the early PD cohort and in the iRBD cohort. Then, state of the art multimodal imaging techniques will be used, including, magnetic resonance imaging (MRI), positron emission tomography (PET) of the dopamine transporters (DAT-PET) to quantify dopamine terminal loss, and \[123I\] MIBG scintigraphy of the heart will be performed to quantify the loss noradrenaline terminals to the heart. In addition to this, synuclein seed amplification assays (SSAs) will be applied to cerebrospinal fluid (CSF) and skin samples to establish synuclein pathology status. Further, CSF and blood biomarkers will be developed that can be used to as prognostic markers. These investigations will be done in parallel to clinical assessments of motor and non-motor symptoms as well as assessment of cognitive function in a longitudinal setting.
CONDITIONS
Official Title
The Swedish BioFINDER Sleep Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Polysomnography verified idiopathic REM sleep behavior disorder according to AASM criteria for iRBD group
- Does not meet diagnostic criteria for idiopathic Parkinson's disease (iRBD group)
- Diagnosis of idiopathic Parkinson's disease for early PD group
- Early PD patients are new or treated for a maximum of 3 years
- Age between 50 and 100 years
- Women under 55 years must take a pregnancy test before PET and scintigraphy if not post-menopausal
- Ability to give informed consent
- Speaks and understands Swedish without need for an interpreter
- Healthy controls have no diagnosis of PD, RBD, or other significant neurological disorders
You will not qualify if you...
- History of severe or repeated concussive head injury, stroke, or significant systemic disease or unstable medical condition
- History of severe and unstable depression, schizophrenia, schizoaffective disorder, or bipolar disorder
- Significant white matter microvascular disease
- Contraindications to MRI and PET scans
- Early PD patients with normal dopamine transporter PET scan ([18F]FE-PE2I)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Skane University Hospital
Malmö, Sweden, 392 33
Actively Recruiting
Research Team
E
Erik Stomrud, MD, PhD
CONTACT
A
Adjmal Nahimi, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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