Dopamine transporter PET scan with… for Parkinson's (BioFINDER-Sleep, NCT07533799)
Predict who will develop Parkinson
- Trial ID
- NCT07533799
- Official Title
- BioFINDER-Sleep: Idiopathic REM-sleep Behavior Disorder & Early Parkinson's Disease
- Study Acronym
- BioFINDER-Sleep
- Goal
- Predict who will develop Parkinson
- 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
Summary For Families
Goal: to understand the early brain and body changes that lead to Parkinson's and related disorders, and to see how REM sleep behavior disorder links with disease progression or a more severe form. Approach: participants have an overnight sleep study, brain scans (magnetic resonance imaging and positron emission tomography to measure loss of dopamine nerve endings), a heart scan using an iodine tracer to measure loss of noradrenaline nerve endings, lab tests on spinal fluid and skin to look for abnormal synuclein protein, blood tests, detailed thinking and movement exams, and continuous monitoring with movement sensors and a phone app, all repeated over several years. The repeated tests aim to find imaging, blood, or spinal fluid markers that predict who will develop Parkinson's or progress faster, and to relate those markers to symptoms. Eligibility: people aged 50 to 100 with early Parkinson's (newly diagnosed or on treatment for up to 3 years), people with polysomnography-confirmed idiopathic REM sleep behavior disorder who do not meet Parkinson's criteria, and healthy controls, all able to consent and speak Swedish.
Locations
- Skane University Hospital, Malmö, Sweden
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Dopamine transporter PET scan with [18F]FE-PE2I. Goal: to understand the early brain and body changes that lead to Parkinson's and related disorders, and to see how REM sleep behavior disorder links with disease progression or a more severe form. Approach: participants have an overnight sleep study, brain scans (magnetic resonance imaging and positron emission tomography to measure loss of dopamine nerve endings), a heart scan using an iodine tracer to measure loss of noradrenaline nerve endings, lab tests on spinal fluid and skin to look for abnormal synuclein protein, blood tests, detailed thinking and movement exams, and continuous monitoring with movement sensors and a phone app, all repeated over several years. The repeated tests aim to find imaging, blood, or spinal fluid markers that predict who will develop Parkinson's or progress faster, and to relate those markers to symptoms. Eligibility: people aged 50 to 100 with early Parkinson's (newly diagnosed or on treatment for up to 3 years), people with polysomnography-confirmed idiopathic REM sleep behavior disorder who do not meet Parkinson's criteria, and healthy controls, all able to consent and speak Swedish.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 11 years and 8 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- How many visits does this trial involve?
- Clinical assessments are done at baseline and after 18, 36, 54 and 72 months (over 72 months total).
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Lumbar puncture (spinal tap) (invasive); Biopsy (invasive); PET scan (minimally invasive); Injection (minimally invasive); Skin biopsy (minimally invasive); MRI scan (non-invasive); Questionnaires & surveys (non-invasive); Wearable / at-home monitoring (non-invasive); Walking & movement tests (non-invasive). Confirm the full schedule with the study coordinator.