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Heart scan may spot hidden brain disease

NCT ID NCT05514106

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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.

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  3. 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

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