The Swedish BioFINDER Sleep Study
Recruiting · NCT07533799 · Observational (researchers observe without assigning treatment) · Lead sponsor: Skane University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 is running
1 location listed.
- Skane University Hospital - Malmö, Sweden