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MIBG Scanning for Lewy Body Disease

Phase 4
Waitlist Available
Led By Bradley Boeve, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

Study Summary

This trial is being done to see if a special radioactive drug called 123I-MIBG can help determine if someone has Lewy Body Disease, a neurologic disorder.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include reactions related to the radioactivity of the drug (such as nausea), sensitivity to iodine in the compound, or issues due to pre-existing kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not taking medications that affect heart imaging tests.
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I have a caregiver with me for at least 4 hours a day, 5 days a week.
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I can make my own medical decisions or have someone who can.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Correlate myocardial 123I-MIBG scintigraphy findings

Trial Design

1Treatment groups
Experimental Treatment
Group I: Myocardial 123I-MIBG scintigraphy imagingExperimental Treatment2 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

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,175 Previous Clinical Trials
3,758,111 Total Patients Enrolled
25 Trials studying Dementia
17,047 Patients Enrolled for Dementia
Bradley Boeve, MDPrincipal InvestigatorMayo Clinic
5 Previous Clinical Trials
3,833 Total Patients Enrolled
4 Trials studying Dementia
3,498 Patients Enrolled for Dementia

Media Library

123I-MIBG scintigraphy Clinical Trial Eligibility Overview. Trial Name: NCT05514106 — Phase 4
Dementia Research Study Groups: Myocardial 123I-MIBG scintigraphy imaging
Dementia Clinical Trial 2023: 123I-MIBG scintigraphy Highlights & Side Effects. Trial Name: NCT05514106 — Phase 4
123I-MIBG scintigraphy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05514106 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the minimum age for participation in this trial at least twenty years old?

"Complying with the standards of this experiment, only individuals between 40 and 90 years old are qualified to be enrolled."

Answered by AI

Could I be eligible to join this clinical research project?

"This investigation requires 50 individuals with dementia, between the ages of 40 and 90. Participants must adhere to a few additional prerequisites; they should have an established diagnosis, no active medical issue that would invalidate participation, regular medication consumption over the last four weeks, assistance from a caregiver for at least 4 hours daily five days per week if applicable, willingness to complete all trial-related activities from both patient and guardian where necessary as well as capacity or sanctioned ability in providing informed consent. Moreover, certain medicines may influence myocardial 123I-MIBG scintigraphy results so their presence is disallowed."

Answered by AI

Is 123I-MIBG scintigraphy a risk free procedure for individuals?

"The safety of 123I-MIBG scintigraphy has been established as it is a Phase 4 trial, thus receiving a score of 3."

Answered by AI

Is enrollment in this trial currently available?

"Per the information accessible on clinicaltrials.gov, this medical investigation is not presently recruiting patients. Published on December 1st 2022 and most recently revised on October 17th 2022, it appears that recruitment has been halted; however, there are currently 1260 additional studies looking for participants as of now."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
How old are they?
65+
What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Met criteria
~31 spots leftby Sep 2025