MIBG in Aging and Neurologic Disorders (NCT05514106) | Clinical Trial Compass
By InvitationPhase 4
MIBG in Aging and Neurologic Disorders
United States50 participantsStarted 2023-05-08
Plain-language 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.
Who can participate
Age range
40 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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 inap…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.