Distinguish Parkinson from related disorders
- Trial ID
- NCT07509125
- Official Title
- Ultra-High Resolution PET of the Human Brain and Spinal Cord in Healthy Aging, Dementia, Movement Disorders, ALS and Psychotic Disorders
- Goal
- Distinguish Parkinson from related disorders
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Study Type
- INTERVENTIONAL
- Enrollment
- 300 participants
- Conditions
- Alzheimer Dementia (AD), ALS - Amyotrophic Lateral Sclerosis, Parkinson s Disease, REM Sleep Behavior Disorder (iRBD), PSP - Progressive Supranuclear Palsy, MSA - Multiple System Atrophy, Dementia With Lewy Bodies (DLB), ALS With Frontotemporal Dementia (ALS/FTD), Adult Onset Psychotic Disorder, Very Late Onset Psychotic Disorder
- Interventions
- UHR PET/CT scan of the brain with ¹⁸F-FDG, UHR PET/CT scan of the brain with ¹⁸F-PE2I, UHR PET/CT scan of the brain with ¹⁸F-SynVesT-1, UHR PET/CT scan of the brain with ¹⁸F-MK6240, 3T MRI imaging of the brain
Summary For Families
The goal is to create ultra-high resolution maps of metabolism, dopamine terminals, synapses and tau in the brain and spinal cord, so clinicians can better tell Parkinson's and related disorders apart and spot early changes. Participants get PET scans with 18F-FDG to measure glucose use, 18F-PE2I to image dopamine transporters and reveal nigrostriatal nerve terminal loss, 18F-SynVesT-1 to quantify synaptic density, and 18F-MK6240 to detect tau, plus a 3T MRI; these are diagnostic imaging tests, they do not treat symptoms and do not interact with levodopa. The study enrolls healthy adults and people with a range of conditions, including Parkinson's, dementia syndromes, ALS, movement disorders, REM sleep behavior disorder and psychosis. For Parkinson's specifically, adults aged 18 to 90 with clinically established PD by MDS criteria, an abnormal 18F-PE2I PET, and no significant cognitive impairment (MoCA 26 or higher) who can tolerate PET/MRI are eligible.
Locations
- UZ Leuven, Leuven, Vlaams-Brabant, Belgium
Frequently Asked Questions
- What is this trial testing?
- This trial is studying UHR PET/CT scan of the brain with ¹⁸F-FDG. The goal is to create ultra-high resolution maps of metabolism, dopamine terminals, synapses and tau in the brain and spinal cord, so clinicians can better tell Parkinson's and related disorders apart and spot early changes. Participants get PET scans with 18F-FDG to measure glucose use, 18F-PE2I to image dopamine transporters and reveal nigrostriatal nerve terminal loss, 18F-SynVesT-1 to quantify synaptic density, and 18F-MK6240 to detect tau, plus a 3T MRI; these are diagnostic imaging tests, they do not treat symptoms and do not interact with levodopa. The study enrolls healthy adults and people with a range of conditions, including Parkinson's, dementia syndromes, ALS, movement disorders, REM sleep behavior disorder and psychosis. For Parkinson's specifically, adults aged 18 to 90 with clinically established PD by MDS criteria, an abnormal 18F-PE2I PET, and no significant cognitive impairment (MoCA 26 or higher) who can tolerate PET/MRI are eligible.
- Who can participate?
- Participants must be between 18 Years and 90 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 3 years and 7 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.