Brain scan study aims to sharpen diagnosis of Parkinson's and dementia

NCT ID NCT01453127

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study uses a special brain scan called DaTscan to look at how certain brain diseases affect the brain. Researchers will scan 500 adults with conditions like Parkinson's disease, dementia, mild cognitive impairment, or REM sleep behavior disorder. The goal is to see if DaTscan can help doctors tell these conditions apart more accurately and improve understanding of how they develop.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
I-123 Ioflupane (DaTscan) injection
What this could lead to
If successful, this could improve how doctors diagnose and distinguish between different neurodegenerative diseases, leading to earlier and more accurate diagnoses.
What could go wrong
This is an observational imaging study, not a treatment trial. It may not directly change patient outcomes, and results may not apply to all populations.

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 500 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Oct 2011

Expected to finish

Dec 2026

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 of interest using established criteria * Age 40-90 inclusive * MMSE 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 DaTscan 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 * Age \<40 or \>90 * 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 * MMSE score \<10 * Active medical disorder that could preclude participation in this protocol * Hypersensitivity to the radioligand, cocaine, or iodine (including seafood allergy) * Myocardial infarction or cerebral infarct over preceding year, stable or unstable angina, known symptomatic coronary artery disease * Renal or liver disease viewed by the physician to be too severe to warrant DaTscan infusion/imaging * History of significant alcohol or drug abuse * Any other medical disorder considered by the study physicians as inappropriate for 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

Only the study team decides who joins. These are the ways to reach them.

  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.

    Open the record ↗

  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

    Rochester, Minnesota, 55905, United States

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