Clinical trial · NCT01453127 · ENROLLING_BY_INVITATION · PHASE4
DaTSCAN Imaging in Aging and Neurodegenerative Disease
Sponsor: Mayo Clinic
Summary
The investigators propose using DaTscan in patients with REM sleep behavior disorder (RBD), mild cognitive impairment (MCI), Parkinson's disease (PD), dementia with Lewy bodies (DLB), Alzheimer's disease (AD), and other neurodegenerative syndromes and disorders, to test several hypotheses - some confirmatory, and some novel. Such use will provide new data on the potential clinical and research utility of DaTscan in neurodegenerative diseases. The findings on DaTscan will be correlated with clinical diagnoses and other multimodal imaging studies (e.g., MRI, MRS, FDG-PET, and amyloid-PET) to enhance our understanding of neurodegenerative diseases.
Interventions
- I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) · DRUG
I-123 Ioflupane solution for injection into a living test subject. The iodine introduced during manufacture is a radioactive isotope, I-123, and it is the properties of this isotope that makes the solution visible to a gamma camera on SPECT imaging. I-123 has a half-life of approximately 13 hours and a gamma photon energy of 159 keV making it an good radionuclide for medical imaging. DaTscan is administered by intravenous cannula. The scan is carried out 3-6 hours post injection.
- Single photon emission computed tomography (SPECT) scan · DEVICE
Single-photon emission computed tomography(SPECT)is a nuclear medicine tomographic imaging technique using gamma rays. It is very similar to conventional nuclear medicine planar imaging using a gamma camera. However, it is able to provide true 3D information. This information is typically presented as cross-sectional slices through the patient, but can be freely reformatted or manipulated as required.
Published eligibility criteria
Verbatim from the registry. Only the site can decide how these apply to a specific patient.
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
Sites (1)
- Mayo Clinic, Rochester, Minnesota
Not medical advice. Trial0 is a navigation service, not a medical provider. Nothing here is medical advice or a recommendation to pursue any treatment; eligibility matching is informational, based on published registry criteria, and only the trial site or treating clinician can determine actual eligibility. Decisions belong with the patient and their own doctors. Registry data refreshed at most hourly; last update posted 2026-03-10.