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
Summary For Families
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, Malmö, 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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.