Brain scan study aims to sharpen diagnosis of Parkinson's and dementia
NCT ID NCT01453127
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Oct 2011
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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40 to 90 years
- Sex
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Anyone
- Healthy volunteers
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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 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 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.
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The places running it
1 site. The list below names each one and where it is.
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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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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
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Other studies related to the condition(s) this trial covers.
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- ACTIVE: adding life to years in cognitive frailty by preventing falls
- Parkinson's improvement activated by hula understanding (PAHU) - part 2
- Half a million people join quest to decode Parkinson's risk
- Can a home feeding coach keep dementia patients out of the hospital?