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.
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.
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.
Individuals with iRBD: Community-based, not restricted to geographical location. But fluency in Swedish and availability to attend repeated visits over the course of 72 months at the site in Malmö, Sweden, is required. Early Parkinson's disease: Patient from the Neurologic clinic at Skåne University Hospital, Sweden. Also patients from other neurological clinics in the county of Skåne, Sweden. Healthy controls: Community-based in the surroundings of Skåne University Hospital, Sweden.
Cohort
Prospective
Dopamine transporter PET scan with [18F]FE-PE2I
Diagnostic testPositron emission tomography (PET) imaging of dopamine transporters (DAT-PET) to quantify dopamine terminal loss.
Magnetic resonance imaging (MRI)
Diagnostic testDifferent MRI sequences relevant for brain imaging and with focus on dopamine associated structures of the brain.
[123I] MIBG scintigraphy of the heart
Diagnostic testMIBG scintigraphy to quantify the loss noradrenaline terminals to the heart.
α-synuclein seeding amplification assays
Diagnostic testsynuclein seed amplification assays (SSAs) will be applied to cerebrospinal fluid (CSF) and skin samples to establish synuclein pathology status
Polysomnography
Diagnostic testPolysomnography to establish presence of REM-sleep behavior disorder
Smell test
Diagnostic testSniffin' Sticks test to quantify hyposmia or anosmia.
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"
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.
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.
Correlation of changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) to imaging and fluid biomarkers
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"
Correlation of changes in Mini-Mental State Examination (MMSE) to imaging and fluid biomarkers
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.
Correlation between objective testing of motor function by clinician and digital biomarkers of motor function
Click on the lead sponsor to view all of their trials.
Skane University Hospital
Lead sponsor
Lund University
Collaborator
