Accurately diagnose Lewy body dementia
- Trial ID
- NCT06120049
- Official Title
- Prospective Head-to-head Comparison of Cardiac [18F]-MFBG PET Versus [123I]-MIBG SPECT in the Differentiation Between Parkinson's Disease and Multiple System Atrophy and Between Dementia With Lewy Bodies and Alzheimer's Disease
- Goal
- Accurately diagnose Lewy body dementia
- Phase
- PHASE2, PHASE3
- Status
- RECRUITING
- Sponsor
- prof. dr. Koen Van Laere
- Study Type
- INTERVENTIONAL
- Enrollment
- 113 participants
- Conditions
- Parkinson Disease, Dementia With Lewy Bodies, MSA - Multiple System Atrophy, Alzheimer Disease
- Interventions
- [18F]-MFBG PET CT, [18F]-FE-PE2I PET CT or PET MRI, [123I]-MIBG SPECT CT, [18F]-MFBG PET dosimetry scans
Summary For Families
The goal is to see if a newer PET scan, cardiac [18F]-MFBG, can more accurately tell Parkinson's disease from multiple system atrophy, and dementia with Lewy bodies from Alzheimer's, by measuring how healthy the heart's sympathetic nerves are. The approach uses [18F]-MFBG PET to image the norepinephrine transporter in cardiac nerves, which gives more quantitative, higher-resolution data than standard [123I]-MIBG SPECT; participants also get brain DAT scans like [18F]-FE-PE2I to confirm dopaminergic loss, and dosimetry scans check radiation exposure. They are looking for adults 45 to 85 with clinically established PD or MSA-P, adults 50 to 85 with probable DLB or Alzheimer's, and healthy volunteers aged 18 to 85. Key requirements include the ability to give informed consent, prior abnormal DAT imaging for many patient groups, and no major heart disease or medications that interfere with the cardiac norepinephrine transporter or PET/MR scanning.
Locations
- UZ Ghent, Ghent, Gent, Belgium
- UZ Leuven, Leuven, Vlaams-Brabant, Belgium
Frequently Asked Questions
- What is this trial testing?
- This trial is studying [18F]-MFBG PET CT. The goal is to see if a newer PET scan, cardiac [18F]-MFBG, can more accurately tell Parkinson's disease from multiple system atrophy, and dementia with Lewy bodies from Alzheimer's, by measuring how healthy the heart's sympathetic nerves are. The approach uses [18F]-MFBG PET to image the norepinephrine transporter in cardiac nerves, which gives more quantitative, higher-resolution data than standard [123I]-MIBG SPECT; participants also get brain DAT scans like [18F]-FE-PE2I to confirm dopaminergic loss, and dosimetry scans check radiation exposure. They are looking for adults 45 to 85 with clinically established PD or MSA-P, adults 50 to 85 with probable DLB or Alzheimer's, and healthy volunteers aged 18 to 85. Key requirements include the ability to give informed consent, prior abnormal DAT imaging for many patient groups, and no major heart disease or medications that interfere with the cardiac norepinephrine transporter or PET/MR scanning.
- Who can participate?
- Participants must be between 18 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- 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 Phase 2/Phase 3 trial is estimated to last approximately 2 years and 5 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.