Parkinson´s DiseaseREM Sleep Behavior Disorder (iRBD)Lewy Body DiseaseSynucleinopathySynucleinopathies
Investigational drug(s) / intervention(s)
Dopamine transporter PET scan with [18F]FE-PE2IMagnetic resonance imaging (MRI)[123I] MIBG scintigraphy of the heartα-synuclein seeding amplification assaysPolysomnographySmell test
Dopamine transporter PET scan with [18F]FE-PE2I: Positron emission tomography (PET) imaging of dopamine transporters (DAT-PET) to quantify dopamine terminal loss.
Magnetic resonance imaging (MRI): Different MRI sequences relevant for brain imaging and with focus on dopamine associated structures of the brain.
[123I] MIBG scintigraphy of the heart: MIBG scintigraphy to quantify the loss noradrenaline terminals to the heart.
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
Polysomnography: Polysomnography to establish presence of REM-sleep behavior disorder
Smell test: Sniffin' Sticks test to quantify hyposmia or anosmia.
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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
100 Years
Healthy volunteers
Accepted
Inclusion Criteria:
Idiopathic RBD:
* 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.
* Speaks and understands Swedish to the extent that an interpreter is not necessary for the patient to fully understand the study information and cognitive tests.
Early Parkinson´s disease:
* Fulfills the diagnostic criteria for idiopathic Parkinson´s disease.
* The PD patients will be de novo (yet without any PD treatment) or with treatment for a maximum of 3 years.
* 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.
* Speaks Swedish fluently as stated above. Healthy Controls
* 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.
* No diagnosis of PD or another significant neurological disorder.
* No diagnosis of RBD.
* Ability to give informed consent.
* Speaks Swedish fluently as stated above.
Exclusion Criteria:
For all groups:
* 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.
Exclusion criteria specific for early Parkinson´s disease:
* Normal dopamine transporter (\[18F\]FE-PE2I) scan.
Primary outcome measure(s)
Longitudinal Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) — From baseline to the end of follow-up 72 months later 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) — From baseline to the end of follow-up 72 months later 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 — From baseline to the end of follow-up 72 months later 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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