RecruitingNCT07533799

The Swedish BioFINDER Sleep Study

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


Sponsor

Skane University Hospital

Enrollment

650 participants

Start Date

Oct 1, 2021

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 50 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Dopamine transporter PET scan with [18F]FE-PE2I, Magnetic resonance imaging (MRI), and others for people with lewy body disease, parkinson's disease, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 50 Years to 100 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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

DIAGNOSTIC_TESTMagnetic 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_TESTα-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_TESTPolysomnography

Polysomnography to establish presence of REM-sleep behavior disorder

DIAGNOSTIC_TESTSmell test

Sniffin' Sticks test to quantify hyposmia or anosmia.


Locations(1)

Skane University Hospital

Malmö, Sweden

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NCT07533799


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