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
Study goal: The goal of this prospective head to head comparison is to evaluate the effectiveness of \[18F\]-MFBG PET in assessing cardiac innervation, comparing it with \[123I\]-MIBG SPECT The study's primary focus is on distinguishing between Parkinson's disease (PD) and multiple system atrophy (MSA), as well as between dementia with Lewy bodies (DLB) and Alzheimer's disease (AD). Main questions: * Feasibility: How well can \[18F\]-MFBG PET detect changes in myocardial uptake in PD and DLB compared to the expected normal values in healthy individuals and AD and MSA-P patients? How well can it differentiate between these groups based on the detected changes? * Non-inferiority: Is \[18F\]-MFBG PET as accurate as \[123I\]-MIBG SPECT in distinguishing between PD and MSA-P, and between DLB and AD? Participant requirements: For the main study, participants will be required to visit the hospital for 3 or 4 appointments. During these visits, they will undergo a screening visit, MRI brain scan, a comprehensive neurological assessment, \[18F\]-PE2I PET, \[123I\]-MIBG SPECT, and \[18F\]-MFBG PET scans. Additionally, a separate dosimetry study will be conducted, involving healthy subjects who will visit the hospital for a screening visit and undergo \[18F\]-MFBG PET scans.
• Healthy Controls:
‣ Voluntary written informed consent.
⁃ Use of highly effective methods of birth control.
⁃ Age between 18 and 85 years.
⁃ Good health based on medical history, physical examination, clinical laboratory tests, and urinalysis.
⁃ No history or evidence of major neurological, internal, or psychiatric disorders.
⁃ Normal structural MRI scan for subjects \< 60 years or minor lesions for subjects \>= 60 years.
• Parkinson's Disease:
‣ Age 45-85 years.
⁃ Clinically established PD based on Movements Disorder Society diagnostic criteria.
⁃ Disease duration since onset of motor symptoms: 5 years or longer for one group and less than 5 years for another.
⁃ Previous abnormal \[18F\]-FE-PE2I PET or \[123I\]-FP-CIT SPECT scan.
⁃ Ability to understand the patient information brochure and provide written informed consent.
• Multiple System Atrophy - Parkinsonian Variant:
‣ Age 45-85 years.
⁃ Clinically established or clinically probable MSA-P based on MDS diagnostic criteria.
⁃ Previous abnormal \[18F\]-FE-PE2I PET or \[123I\]-FP-CIT SPECT scan.
⁃ Ability to understand the patient information brochure and provide written informed consent.
• Dementia Due to Alzheimer's Disease:
‣ Age 50-85 years.
⁃ Diagnosis of probable AD with evidence of the AD pathophysiological process.
⁃ Ability to understand the patient information brochure and provide written informed consent.
• Dementia with Lewy Bodies:
‣ Age 50-85 years.
⁃ Diagnosis of probable DLB.
⁃ Previous abnormal \[18F\]-FE-PE2I PET or \[123I\]-FP-CIT SPECT scan.
⁃ Ability to understand the patient information brochure and provide written informed consent.