MIBG in Aging and Neurologic Disorders

• Status: Enrolling by invitation
• Trial end date: 2025-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Treatments: 3-Iodobenzylguanidine

Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• 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

• Patient or caregiver unwilling or unable to participate in all study-related procedures

• Caregiver is not with a patient with dementia or severe parkinsonism at least 4 hours/day for at least 5 days/week

• Patient or caregiver unwilling or unable to provide informed consent