Find tests predicting Parkinson progression
- Trial ID
- NCT07533799
- Official Title
- BioFINDER-Sleep: Idiopathic REM-sleep Behavior Disorder & Early Parkinson's Disease
- Goal
- Find tests predicting Parkinson progression
- Status
- RECRUITING
- Sponsor
- Skane University Hospital
- Study Type
- OBSERVATIONAL
- Enrollment
- 650 participants
- Conditions
- Parkinson´s Disease, REM Sleep Behavior Disorder (iRBD), Lewy Body Disease, Synucleinopathy, Synucleinopathies
- Interventions
- Dopamine transporter PET scan with [18F]FE-PE2I, Magnetic resonance imaging (MRI), [123I] MIBG scintigraphy of the heart, α-synuclein seeding amplification assays, Polysomnography, Smell test
Plain-Language Summary
Goal: to find brain and body markers that show whether idiopathic REM sleep behavior disorder (iRBD) reflects early Lewy body disease and to track early Parkinson's progression. Approach: participants undergo dopamine transporter PET with [18F]FE-PE2I to measure loss of dopamine nerve endings, cardiac [123I]MIBG to test heart sympathetic denervation, MRI for brain structure, alpha-synuclein seeding amplification assays to detect misfolded alpha-synuclein, overnight polysomnography to confirm RBD, and smell testing; it is observational, so there is no experimental drug and it will not alter usual PD medications. Eligibility: ages 50 to 100, with groups for polysomnography-verified iRBD who do not meet PD criteria, early Parkinson's patients who are treatment naive or treated for up to 3 years, and healthy controls with no RBD or neurologic disease, all able to give consent and speak Swedish. Exclusions include major medical or psychiatric conditions, significant white matter disease, contraindications to MRI or PET, and for the PD group a normal dopamine transporter scan.
Locations
- Skane University Hospital, Malmo, Sweden
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Dopamine transporter PET scan with [18F]FE-PE2I. Goal: to find brain and body markers that show whether idiopathic REM sleep behavior disorder (iRBD) reflects early Lewy body disease and to track early Parkinson's progression. Approach: participants undergo dopamine transporter PET with [18F]FE-PE2I to measure loss of dopamine nerve endings, cardiac [123I]MIBG to test heart sympathetic denervation, MRI for brain structure, alpha-synuclein seeding amplification assays to detect misfolded alpha-synuclein, overnight polysomnography to confirm RBD, and smell testing; it is observational, so there is no experimental drug and it will not alter usual PD medications. Eligibility: ages 50 to 100, with groups for polysomnography-verified iRBD who do not meet PD criteria, early Parkinson's patients who are treatment naive or treated for up to 3 years, and healthy controls with no RBD or neurologic disease, all able to give consent and speak Swedish. Exclusions include major medical or psychiatric conditions, significant white matter disease, contraindications to MRI or PET, and for the PD group a normal dopamine transporter scan.
- Who can participate?
- Participants must be between 50 Years and 100 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 11 years and 8 months.