The Swedish BioFINDER Sleep Study

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.

Conditions

• Parkinson´s Disease
• REM Sleep Behavior Disorder (iRBD)
• Lewy Body Disease
• Synucleinopathy
• Synucleinopathies

Interventions

DIAGNOSTIC_TEST

Dopamine transporter PET scan with [18F]FE-PE2I

Positron emission tomography (PET) imaging of dopamine transporters (DAT-PET) to quantify dopamine terminal loss.

DIAGNOSTIC_TEST

Magnetic resonance imaging (MRI)

Different MRI sequences relevant for brain imaging and with focus on dopamine associated structures of the brain.

DIAGNOSTIC_TEST

[123I] MIBG scintigraphy of the heart

MIBG scintigraphy to quantify the loss noradrenaline terminals to the heart.

DIAGNOSTIC_TEST

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

DIAGNOSTIC_TEST

Polysomnography

Polysomnography to establish presence of REM-sleep behavior disorder

DIAGNOSTIC_TEST

Smell test

Sniffin' Sticks test to quantify hyposmia or anosmia.

Sponsors & Collaborators

• Lund University

  collaborator OTHER

• Skane University Hospital

  lead OTHER

Principal Investigators

• Erik Stomrud, MD, PhD · Skane University Hospital and Lund University

Eligibility

Min Age

50 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-10-01

Primary Completion

2033-06-30

Completion

2033-06-30

Countries

• Sweden

Study Locations