MIBG in Aging and Neurologic Disorders

Dementia Clinical Trial

Official title:

Myocardial 123I-MIBG Scintigraphy in Aging and Neurodegenerative Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05514106
• Other study ID #: 21-012740
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: May 8, 2023
• Est. completion date: September 2025

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Lewy Body Disease
• Mental Disorders
• Mild Cognitive Impairment
• Parkinsonian Disorders
• Parkinsonism
• REM Sleep Behavior Disorder

Intervention

Drug:
• meta-iodobenzylguanidine (MIBG) (123I)
1 administration of 123I-MIBG for a single SPECT scan

Diagnostic Test:
• 123I-MIBG scintigraphy
SPECT scan involving 123I-MIBG as the ligand

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlate myocardial 123I-MIBG scintigraphy findings	Number of myocardial 123I-MIBG scintigraphy findings to correlate with clinical pathologic diagnosis	10 years