Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT05514106 |
Other study ID # |
21-012740 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
May 8, 2023 |
Est. completion date |
September 2025 |
Study information
Verified date |
May 2023 |
Source |
Mayo Clinic |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
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.