MIBG in Aging and Neurologic Disorders

NCT05514106 | Enrolling By Invitation Phase 4 FDA Device

• 1 other identifier: 21-012740
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lewy Body Disease; Dementia; Parkinsonism; Mild Cognitive Impairment; REM Sleep Behavior Disorder

Keywords

REM Sleep without atonia; Normal Neurologic functioning

Outcome Measures

Primary Outcomes (1)

• Correlate myocardial 123I-MIBG scintigraphy findings

  Number of myocardial 123I-MIBG scintigraphy findings to correlate with clinical pathologic diagnosis

  10 years

Study Arms (1)

Myocardial 123I-MIBG scintigraphy imaging

EXPERIMENTAL

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

Interventions

meta-iodobenzylguanidine (MIBG) (123I) DRUG

1 administration of 123I-MIBG for a single SPECT scan

Also known as: 123I-MIBG

Myocardial 123I-MIBG scintigraphy imaging

123I-MIBG scintigraphy DIAGNOSTIC_TEST

SPECT scan involving 123I-MIBG as the ligand

Myocardial 123I-MIBG scintigraphy imaging

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lewy Body Disease; Dementia; Parkinsonian Disorders; Cognitive Dysfunction; REM Sleep Behavior Disorder

Interventions

3-Iodobenzylguanidine; Iodine-123

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Iodobenzenes; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hydrocarbons, Iodinated; Hydrocarbons, Halogenated

Study Officials

• Bradley Boeve, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 24, 2022
• Study Start: May 8, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)