The Swedish BioFINDER Sleep Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-100
SponsorSkane University Hospital

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Dopamine transporter PET scan with [18F]FE-PE2I
  • Magnetic resonance imaging (MRI)
  • [123I] MIBG scintigraphy of the heart
  • α-synuclein seeding amplification assays
  • Polysomnography
  • Smell test

Treatment groups

650 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Skane University Hospital

Lead sponsor

Lund University

Collaborator