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The Swedish BioFINDER Sleep Study
Sponsor: Skane University Hospital
Summary
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.
Official title: BioFINDER-Sleep: Idiopathic REM-sleep Behavior Disorder & Early Parkinson's Disease
Key Details
Gender
All
Age Range
50 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
650
Start Date
2021-10-01
Completion Date
2033-06
Last Updated
2026-04-16
Healthy Volunteers
Yes
Conditions
Interventions
Dopamine transporter PET scan with [18F]FE-PE2I
Positron emission tomography (PET) imaging of dopamine transporters (DAT-PET) to quantify dopamine terminal loss.
Magnetic resonance imaging (MRI)
Different MRI sequences relevant for brain imaging and with focus on dopamine associated structures of the brain.
[123I] MIBG scintigraphy of the heart
MIBG scintigraphy to quantify the loss noradrenaline terminals to the heart.
α-synuclein seeding amplification assays
synuclein seed amplification assays (SSAs) will be applied to cerebrospinal fluid (CSF) and skin samples to establish synuclein pathology status
Polysomnography
Polysomnography to establish presence of REM-sleep behavior disorder
Smell test
Sniffin' Sticks test to quantify hyposmia or anosmia.
Locations (1)
Skane University Hospital
Malmo, Sweden