Heart scan may spot hidden brain disease
NCT ID NCT05514106
First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This study tests whether a special heart scan using a radioactive drug called 123I-MIBG can help identify Lewy body disease, a type of dementia that also affects movement and sleep. Researchers will compare scan results with clinical diagnoses in 50 people who have conditions like dementia, Parkinsonism, mild cognitive impairment, or REM sleep behavior disorder. The goal is to see if the scan can improve prediction of the underlying disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a radioactive drug called 123I-MIBG, given once for a heart scan
- What this could lead to
- If it works, this scan could become a reliable tool to diagnose Lewy body disease earlier and more accurately.
- What could go wrong
- This is a small, early-phase study, so the scan may not prove accurate enough for routine use. The radioactive drug carries a small radiation risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2023
- Expected to finish
-
Sep 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
40 to 90 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 inappropriate for enrollment in this protocol * Patient or caregiver unwilling or unable to participate in all study-related procedures * Caregiver is not with a patient with dementia or severe parkinsonism at least 4 hours/day for at least 5 days/week * Patient or caregiver unwilling or unable to provide informed consent
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Dementia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a massive data registry crack the code of Parkinson's and related brain diseases?
- A simple gel meets the Mouth's microscopic zoo
- Reading the Brain's signals to predict who benefits from deep brain stimulation
- Walking memory tests may reveal early Parkinson's clues
- Giving Parkinson's patients a say may boost their Brain's ability to learn movement
- Brain scans probe why some Parkinson's patients freeze Mid-Step