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
Plain-Language Summary
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.