Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

650

participants targeted

Target at P75+ for all trials

Timeline

87mo left

Started Oct 2021

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11.7 years study duration

Study Progress39%

Oct 2021Jun 2033

Study Start

First participant enrolled

October 1, 2021

Completed

4.5 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2026

Completed

15 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed

7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2033

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2033

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

11.7 years

First QC Date

April 1, 2026

Last Update Submit

April 9, 2026

Conditions

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

Keywords

Early diagnosisCSFPlasmaPETMRIDAT PETSmell testsynuclein seed amplification assaysMIBGPolysomnographyα-synucleinMotoric testcognitive testUPDRS

Outcome Measures

Primary Outcomes (3)

Longitudinal Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Will be evaluated at each follow-up visit every 18 months. The MDS-UPDRS is a clinical rating tool used to assess both motor and non-motor symptoms of Parkinson's disease, as well as their effect on activities of daily living. It is divided into 4 subparts and cotains questions and clinical evaluations. Part 1 and 2 each contain 13 questions. Each question is scored from 0 to 4, where higher scores indicate more severe symptoms. The maximum score for each of these parts is 52. Part 3 is a clinical examination of motor symptoms. It includes 33 items, also scored from 0 to 4. The maximum score for this section is 132. Part 4 assesses motor complications and contains 6 items, scored from 0 to 4. The maximum score for this part is 24"
From baseline to the end of follow-up 72 months later
Longitudinal Changes in Mini-Mental State Examination (MMSE)
Will be evaluated at each follow-up visit every 18 months. MMSE screens for cognitive impairment and score from 0-30 points where higher points indicate better cognitive function.
From baseline to the end of follow-up 72 months later
Time to phenoconversion from iRBD to manifest parkinsonian disorders
Time to phenoconversion from diagnosis of iRBD to manifestation of a parkinsonian disorders according to clinical diagnostic criteria as evaluated at consensus group decision at the last visit.
From baseline to the end of follow-up 72 months later

Secondary Outcomes (3)

Correlation of changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) to imaging and fluid biomarkers
From baseline to the end of follow-up 72 months later
Correlation of changes in Mini-Mental State Examination (MMSE) to imaging and fluid biomarkers
From baseline to the end of follow-up 72 months later.
Correlation between objective testing of motor function by clinician and digital biomarkers of motor function
From baseline to the end of follow-up 72 months later

Study Arms (3)

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.

Diagnostic Test: Dopamine transporter PET scan with [18F]FE-PE2IDiagnostic Test: Magnetic resonance imaging (MRI)Diagnostic Test: [123I] MIBG scintigraphy of the heartDiagnostic Test: α-synuclein seeding amplification assaysDiagnostic Test: PolysomnographyDiagnostic Test: Smell test

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.

Interventions

Dopamine transporter PET scan with [18F]FE-PE2IDIAGNOSTIC_TEST

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