DaTSCAN Imaging in Aging and Neurodegenerative Disease

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT01453127
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Dementia
  • Mild Cognitive Impairment
  • Parkinsonism
  • REM Sleep Behavior Disorder

Eligibility Criteria

Sex
ALL
Age
40 Years - 90 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Oct 31, 2011
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
500 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Alzheimer's Disease
    Alzheimer's Disease
  • Experimental: Dementia with Lewy Bodies
    Dementia with Lewy Bodies
  • Experimental: Frontotemporal Dementia
    Frontotemporal Dementia
  • Experimental: Parkinson's Disease
    Parkinson's Disease
  • Experimental: Corticobasal Degeneration
    Corticobasal Degeneration
  • Experimental: Essential Tremor
    Essential Tremor
  • Experimental: Mild Cognitive Impairment
    Mild Cognitive Impairment
  • Experimental: REM sleep behavior disorder
    REM sleep behavior disorder

Primary Outcome Measure

Correlate the DaTscan findings with clinical diagnosis [ Time Frame: Participants will be followed to 1-3 days after scan. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-

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By research site
Mayo Clinic· Rochester, MN

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