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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 100
Healthy Volunteers: t
View:

⁃ 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.

Locations
Other Locations
Sweden
Skane University Hospital
RECRUITING
Malmo
Contact Information
Primary
Erik Stomrud, MD, PhD
erik.stomrud@med.lu.se
+46 40 33 10 00
Backup
Adjmal Nahimi, MD, PhD
adjmal.nahimi@med.lu.se
+46 40 33 10 00
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2033-06
Participants
Target number of participants: 650
Treatments
Idiopathic REM-sleep Behavior Disorder (iRBD)
200 individuals with iRBD will be recruited through advertisement or due to being under clinical investigation for the condition at any clinic in the county of Skåne, Sweden.
Early Parkinson´s disease
200 patients with early Parkinson's disease will be recruited from the Neurology clinic at Skåne University Hospital and in addition other Neurology clinics in the county of Skåne, Sweden.
Healthy controls
250 healthy controls will be recruited through advertisement and by personal invitation by mail.
Sponsors
Leads: Skane University Hospital
Collaborators: Lund University

This content was sourced from clinicaltrials.gov