NCT01453127

DaTSCAN Imaging in Aging and Neurodegenerative Disease

Enrolling by Invitation
PHASE4Ages 40–90InterventionalDiagnostic
Mayo Clinic
~500 participants
Updated 2026-03-10 on ClinicalTrials.gov
What's tested:I-123 Ioflupane solution injection prior to SPECT scan (DaTscan)Single photon emission computed tomography (SPECT) scan

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Correlate the DaTscan findings with clinical diagnosis
Measured over Participants will be followed to 1-3 days after scan.
Dementia
Parkinsonism
Mild Cognitive Impairment
REM Sleep Behavior Disorder
1 sites across 1 states
Minnesota1
  • Bradley Boeve, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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
  • Correlate the DaTscan findings with clinical diagnosisParticipants will be followed to 1-3 days after scan.

    The primary endpoint is to correlate the DaTscan findings with clinical diagnosis