MIBG Scanning for Lewy Body Disease

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Renal disease, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses a special radioactive drug and a heart scan to help identify Lewy Body Disease in people with certain neurological symptoms. The scan checks how well the heart absorbs the drug to find early signs of this brain disorder.

Will I have to stop taking my current medications?

The trial requires that your medication regimen has been stable for the previous four weeks, and you must not be taking certain medications that could affect the scan results. It's best to discuss your current medications with the study team to see if any changes are needed.

What data supports the effectiveness of the treatment 123I-MIBG scintigraphy for Lewy Body Disease?

Research shows that 123I-MIBG scintigraphy is useful for diagnosing Lewy Body Disease by helping to differentiate it from other similar conditions, like Parkinson's disease and dementia with Lewy bodies, through imaging of the heart's nerve activity. ^{1 2 3 4 5}

Is MIBG scanning safe for humans?

The research articles provided do not contain specific safety data for MIBG scanning in humans. ^{1 2 3 6 7}

How is the treatment 123I-MIBG scintigraphy unique for Lewy Body Disease?

123I-MIBG scintigraphy is unique because it helps in diagnosing Lewy Body Disease by imaging nerve function in the heart, which is often reduced in these conditions. This imaging technique is particularly useful for distinguishing Lewy Body Disease from other similar disorders like Parkinson's disease and Alzheimer's disease. ^{1 2 3 6 8}

Research Team

Bradley Boeve, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals with certain neurological disorders like Lewy Body Disease, Parkinson's, or dementia. Participants need a caregiver present at least 20 hours per week and must have stable medication use without severe medical conditions that could interfere with the study.

Inclusion Criteria

I have a caregiver with me for at least 4 hours a day, 5 days a week.

You have been diagnosed with one of the specific medical conditions using well-known criteria.

Your STMS score is higher than 10.

Exclusion Criteria

You are allergic to the radioligand or iodine.

I am willing and able to follow all study-related procedures.

Any other medical disorder considered by the study physicians as inappropriate for enrollment in this protocol

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo myocardial 123I-MIBG scintigraphy imaging to assess neurologic and cardiac function

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

10 years

Treatment Details

Interventions

• 123I-MIBG scintigraphy
• meta-iodobenzylguanidine (MIBG) (123I)

Trial Overview The trial tests a radioactive drug called 123I-MIBG and its ability to diagnose Lewy Body Disease through myocardial MIBG scintigraphy scans. It aims to improve disease prediction by correlating scan results with other clinical data.

Participant Groups

Group I: Myocardial 123I-MIBG scintigraphy imaging Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Potential diagnostic value of regional myocardial adrenergic imaging using (123)I-MIBG SPECT to identify patients with Lewy body diseases. [2019]

2. Japan pubmed.ncbi.nlm.nih.gov

Comparison of parameters of (123)I-metaiodobenzylguanidine scintigraphy for differential diagnosis in patients with parkinsonism: correlation with clinical features. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Comparison of the diagnostic performance of H/M ratio between early and delayed phases for Lewy body disease. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Autopsy Validation of the Diagnostic Accuracy of 123I-Metaiodobenzylguanidine Myocardial Scintigraphy for Lewy Body Disease. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Iodine-123 metaiodobenzylguanidine scintigraphy and iodine-123 ioflupane single photon emission computed tomography in Lewy body diseases: complementary or alternative techniques? [2022]

6. Italy pubmed.ncbi.nlm.nih.gov

Recent developments in innervation imaging using iodine-123-metaiodobenzylguanidine scintigraphy in Lewy body diseases. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Impaired myocardial 123I-metaiodobenzylguanidine uptake in Lewy body disease: comparison between dementia with Lewy bodies and Parkinson's disease. [2016]

8. Spain pubmed.ncbi.nlm.nih.gov

[Utility of early imaging of myocardial innervation scintigraphy in the diagnosis of Lewy Body Dementia]. [2016]