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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a special scan using a radioactive drug called 123I-MIBG to help identify Lewy Body Disease, a type of brain disorder. Researchers aim to determine if this scan can enhance the accuracy of diagnosing this condition by comparing it with other tests and exams. Suitable candidates for the trial include individuals with symptoms such as REM sleep issues, Parkinson's symptoms, or cognitive problems, who have maintained a stable treatment plan for the past four weeks. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, and this research seeks to understand how it benefits more patients.

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 is the safety track record for 123I-MIBG scintigraphy?

Research has shown that 123I-MIBG scintigraphy is a trusted and established method for assessing certain heart conditions linked to Lewy body disorders. Studies have demonstrated its accuracy in differentiating between movement disorders such as Parkinson's disease and multiple system atrophy.

Various studies have used this method to monitor heart function, proving it to be a reliable measure not significantly affected by other medical conditions. Reports of side effects are minimal, indicating that patients generally tolerate it well. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about 123I-MIBG scintigraphy for Lewy Body Disease because it offers a unique approach to diagnosing the condition. Unlike traditional methods that rely heavily on clinical assessment and sometimes invasive procedures, 123I-MIBG scintigraphy provides a non-invasive imaging technique that can evaluate heart nerve function. This imaging method uses a radioactive tracer to detect changes in nerve activity that are often present in Lewy Body Disease, potentially allowing for earlier and more accurate diagnosis. By targeting the autonomic nervous system, it could differentiate Lewy Body Disease from other neurodegenerative disorders, offering a clearer diagnostic path.

What evidence suggests that 123I-MIBG scintigraphy is effective for diagnosing Lewy Body Disease?

Research has shown that a special heart scan called 123I-MIBG effectively diagnoses Lewy Body Disease (LBD). Studies demonstrate that this scan can accurately differentiate LBD from conditions like Alzheimer's disease and multiple system atrophy. One study proved this method could correctly identify LBD in patients, even when compared to autopsy results. Another analysis found the scan highly accurate, making it a useful tool for detecting LBD, especially in mild cases. Overall, evidence suggests that 123I-MIBG reliably distinguishes LBD from other similar disorders. Participants in this trial will undergo myocardial 123I-MIBG scintigraphy imaging to further evaluate its effectiveness in diagnosing LBD. ^{3 6 7 8 9}

Who Is on the Research Team?

Bradley Boeve, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5124887/

123I-MIBG myocardial scintigraphy for the evaluation of ... I-MIBG myocardial scintigraphy is useful for distinguishing between LBD and non-LBD including Alzheimer disease, PSP, MSA, vascular dementia, CBD and other ...

2. neurology.org neurology.org/doi/10.1212/WNL.0000000000200110

Autopsy Validation of the Diagnostic Accuracy of 123I- ... This study provides Class II evidence that 123 I-MIBG myocardial scintigraphy accurately identifies patients with LBD.

3. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.23659

Meta‐analysis of 123I‐MIBG cardiac scintigraphy for the ... 123 I-metaiodobenzylguanidine cardiac scintigraphy can accurately distinguish between 2 movement disorders, Parkinson's disease and multiple system atrophy.

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0120540

Diagnostic Accuracy of 123 I-Meta-Iodobenzylguanidine ... The diagnostic accuracy is sufficiently high for this technique to be clinically useful in distinguishing DLB from AD, especially in patients with mild ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2590112525000507

Correlation analyses between MIBG myocardial ... Dementia with Lewy bodies (DLB) remains poorly understood and frequently misdiagnosed, complicated by co-pathology with other dementia forms.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4460541/

123I-Metaiodobenzylguanidine Myocardial Scintigraphy in ... 123 I-metaiodobenzylguanidine (MIBG) scintigraphy is a well-known tool to evaluate cardiac sympathetic denervation in the Lewy body-related disorders.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11401792/

Sympathetic 123I-metaiodobenzylguanidine index for ... The 123 I-MIBG-derived SMILe indexes provide likelihood of LBD, and those with a 50% threshold demonstrated optimal diagnostic accuracy for LBD.

8. academic.oup.com academic.oup.com/braincomms/article/6/3/fcae148/7658814

Reduced cardiac 123I-MIBG uptake is a robust biomarker of ... 123 I-MIBG cardiac uptake is markedly reduced in patients with isolated rapid eye movement sleep behaviour disorder, similar to Parkinson's disease and ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S217358081070078X

123I-MIBG Myocardial Scintigraphy in the Diagnosis of ... Low MIBG myocardial scintigraphy uptake is a robust measure in LBD, and it is not largely affected by medical conditions, or by the stage of the disease.