NCT06120049
[18F]-MFBG Versus [123I]-MIBG and [18F]-PE2I in PD vs. MSA and DLB vs. AD
Recruiting · Phase 2, Phase 3 · prof. dr. Koen Van Laere · registry updated 2025-02-06
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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....
Inclusion
- 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.
Exclusion
- Healthy controls:
- Major diseases that may interfere with the investigations.
- Evidence of cognitive impairment.
- History or evidence of psychiatric disease.
- Use of illicit drugs or history of drug or alcohol abuse.
- Chronic medication interfering with cardiac neuronal norepinephrine transporter (NET) or \[18F\]-FE-PE2I imaging.