PET/CT with 18-FDG for Parkinson's (NCT06629207)

Predict Parkinson risk using imaging

Trial ID
NCT06629207
Official Title
Artificial Intelligence on Molecular Imaging to Predict the Risks of Parkinson's Disease for Patients With Rapid Eye Movement Sleep Behavior Disorder
Goal
Predict Parkinson risk using imaging
Phase
NA
Status
RECRUITING
Sponsor
Insel Gruppe AG, University Hospital Bern
Study Type
INTERVENTIONAL
Enrollment
20 participants
Conditions
Parkinson Disease, REM Sleep Behavior Disorder, Dementia, Lewy Body
Interventions
PET/CT with 18-FDG, SPECT : 123 I-FP-CIT (DATSCAN), MRI

Summary For Families

The team wants to follow people with rapid eye movement sleep behavior disorder over time to find clinical signs and brain-scan markers that predict who will later develop Parkinson's disease, dementia with Lewy bodies, or multiple system atrophy. Participants will have clinical exams and brain imaging, and artificial intelligence will analyze those images to build a reliable way to predict and sort patients by their risk of converting to those conditions. The study seeks adults 18 and older with a confirmed diagnosis of rapid eye movement sleep behavior disorder not caused by another condition, who do not already have Parkinson's or another neurodegenerative disease and who do not have clear signs of Parkinson's on exam, narcolepsy, moderate to severe sleep apnea, or abnormal neurological or brain scan findings.

Locations

  • Inselspital, University Clinic for Nuclear Medicine, Bern, Switzerland

Frequently Asked Questions

What is this trial testing?
This trial is studying PET/CT with 18-FDG. The team wants to follow people with rapid eye movement sleep behavior disorder over time to find clinical signs and brain-scan markers that predict who will later develop Parkinson's disease, dementia with Lewy bodies, or multiple system atrophy. Participants will have clinical exams and brain imaging, and artificial intelligence will analyze those images to build a reliable way to predict and sort patients by their risk of converting to those conditions. The study seeks adults 18 and older with a confirmed diagnosis of rapid eye movement sleep behavior disorder not caused by another condition, who do not already have Parkinson's or another neurodegenerative disease and who do not have clear signs of Parkinson's on exam, narcolepsy, moderate to severe sleep apnea, or abnormal neurological or brain scan findings.
Who can participate?
Participants must be at least 18 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 1 year and 10 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?
Everyone in this trial receives the experimental treatment. There is no placebo group.
What procedures are involved in this trial?
Based on the protocol, this trial involves: PET scan (minimally invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.

Related Reading

View on ClinicalTrials.gov