A Phase 4 interventional study of meta-iodobenzylguanidine (MIBG) (123I) and 123I-MIBG scintigraphy in Lewy Body Disease, Dementia and Parkinsonism, sponsored by Mayo Clinic. Enrolling by invitation at 1 site in United States. Open to participants aged 40 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Diagnostic
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.
Lewy body disease (LBD) is one of the most common neurodegenerative diseases and second only to Alzheimer's disease in terms of prevalence, disability, and societal/financial burden. The clinical variability of LBD is striking, as it can manifest as Parkinson's disease (PD), PD with dementia (PDD), dementia with Lewy bodies (DLB), mild cognitive impairment (MCI), REM sleep behavior disorder (RBD), among other disorders. Considerable evidence now suggests that accumulation of the pathological protein and neuronal loss evolve over decades with RBD and/or MCI beginning years before developing overt DLB or PD.
This project investigates the utility of myocardial 123I-MIBG scintigraphy using a radioactive agent AdreView™ in participants with normal neurologic functioning, REM sleep without atonia, RBD, parkinsonism, cognitive impairment, or some combination of these. This scan may be able to help determine who may have underlying LBD.
Myocardial 123I-MIBG scintigraphy is considered as one of the most important imaging tests in the international diagnostic criteria of DLB, and it is widely used in European countries and Japan. Despite its globally recognized scientific importance, the use of AdreView™ and myocardial 123I-MIBG scintigraphy in DLB and associated disorders is not approved in the US. Currently, the FDA-approved indication of AdreView™ is limited to assessing specific cardiac function and detecting pheochromocytoma or neuroblastoma.
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 detection of LBD. This study will help investigators learn the utility of myocardial 123I-MIBG scintigraphy in identifying LBD in the early course of the disease, and to prepare for clinical trials targeting LBD pathophysiology.
239 studies on the registry are indexed under Lewy Body Disease; 89 are open to participants now.
This study's planned enrollment of 50 is below the median of 89 across 152 interventional studies indexed under Lewy Body Disease.
Browse Lewy Body Disease studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Active medical disorder that could preclude participation in this protocol
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with with normal neurologic functioning, REM sleep without atonia, RBD, parkinsonism, cognitive impairment, or some combination of these will undergo myocardial 123I-MIBG scintigraphy imaging
Drug: meta-iodobenzylguanidine (MIBG) (123I) · Diagnostic Test: 123I-MIBG scintigraphy
1 administration of 123I-MIBG for a single SPECT scan
Also known as: 123I-MIBG
SPECT scan involving 123I-MIBG as the ligand
Correlate myocardial 123I-MIBG scintigraphy findings
Number of myocardial 123I-MIBG scintigraphy findings to correlate with clinical pathologic diagnosis
Time frame: 10 years
Plan to share: No
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for Sep 2027, 52 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: 3-Iodobenzylguanidine