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MIBG Scanning for Lewy Body Disease
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.You are allergic to the radioligand or iodine.I am willing and able to follow all study-related procedures.Your kidney disease is too severe for the imaging test.You have a history of serious alcohol or drug abuse.I am not taking medications that affect heart imaging tests.I do not care for someone with dementia or severe Parkinson's for 4 hours a day, 5 days a week.You have been diagnosed with one of the specific conditions we are studying using recognized criteria.I am not post-menopausal and have a negative pregnancy test.I am currently pregnant or breastfeeding.Your short-term memory score is less than 10.I have a caregiver with me for at least 4 hours a day, 5 days a week.Your STMS score is greater than 10.I can make my own medical decisions or have someone who can.You don't have any of the specific health conditions we are looking for.I have had a heart attack or stroke in the last year, or I have ongoing heart problems.I can make my own medical decisions or have someone who can.You are willing and able to participate in all study-related procedures.I am not taking any medications that could affect heart imaging tests.
- Group 1: Myocardial 123I-MIBG scintigraphy imaging
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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