NCT05514106Enrolling by invitationPhase 4
MIBG in Aging and Neurologic Disorders
Myocardial 123I-MIBG Scintigraphy in Aging and Neurodegenerative Disease
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
The purpose of the study is to investigate the use of a special radioactive drug called 123I-MIBG and myocardial MIBG scintigraphy. This scan may be able to help determine who may have a certain kind of neurologic disorder called Lewy Body Disease. The overall purpose of this study is to correlate myocardial MIBG scintigraphy findings with clinical diagnosis. Myocardial MIBG scintigraphy imaging will be combined with other clinical, neuropsychological and neuroimaging findings to improve the prediction for underlying Lewy Body Disease.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 23 Aug 2022
- Start date
- 8 May 2023
- Primary completion date
- Sept 2027
- Lead sponsor
- Mayo Clinic
- Diseases
- Lewy body dementia
- NCT number
- NCT05514106
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- From 8 May 2023 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active medical disorder that could preclude participation in this protocol
- Hypersensitivity to the radioligand or iodine
- Myocardial infarction or cerebral infarct over preceding year, stable or unstable angina, known symptomatic coronary artery disease
- Renal disease viewed by the physician to be too severe to warrant myocardial 123I-MIBG scintigraphy imaging
- History of significant alcohol or drug abuse
- Any other medical disorder considered by the study physicians as inappropriate for enrollment in this protocol
- Caregiver is not with a patient with dementia or severe parkinsonism at least 4 hours/day for at least 5 days/week
Other
- Does not fulfill criteria for any of the desired diagnoses
- Women with intact uterus and not post-menopausal unless pregnancy test performed at screening is negative
- Women who are pregnant or are breast-feeding an infant
- STMS score \<10
- Patient or caregiver unwilling or unable to participate in all study-related procedures
- Patient or caregiver unwilling or unable to provide informed consent
Who the study is looking for
- Diagnosis of one of the syndromes/diagnoses of interest using established criteria
- STMS score above 10
- No active medical disorder that could preclude participation
- Stable medication regimen over previous four weeks
- Absence of certain medications that could significantly impact the myocardial 123I-MIBG scintigraphy findings
- For those with dementia, caregiver that is with the patient at least 4 hours/day for at least 5 days per week
- For those with dementia, or severe parkinsonism, patient and caregiver willing and able to participate in all study-related procedures
- Patient is capable of giving informed consent, or if appropriate, has caregiver capable of giving consent on the subject's behalf.
Age in the registry: 40 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.