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DaTSCAN Imaging in Aging and Neurodegenerative Disease

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Bradley Boeve, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01453127
First received: September 28, 2011
Last updated: April 18, 2014
Last verified: April 2014

September 28, 2011
April 18, 2014
October 2011
November 2015   (final data collection date for primary outcome measure)
Correlate the DaTscan findings with clinical diagnosis [ Time Frame: Participants will be followed to 1-3 days after scan. ] [ Designated as safety issue: No ]
The primary endpoint is to correlate the DaTscan findings with clinical diagnosis
Same as current
Complete list of historical versions of study NCT01453127 on ClinicalTrials.gov Archive Site
Safety of DaTscan imaging [ Time Frame: Participants will be followed for 1-3 days after scan. ] [ Designated as safety issue: Yes ]
The primary safety/tolerability endpoint relates to side effects associated with DaTscan imaging
Same as current
Not Provided
Not Provided
 
DaTSCAN Imaging in Aging and Neurodegenerative Disease
DaTSCAN Imaging in Aging and Neurodegenerative Disease

The investigators propose using DaTscan in patients with 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.

Lewy body disease (LBD) is one of the most common neurodegenerative diseases and second only to Alzheimer's disease in terms of prevalence, disability, and societal/financial burden. The phenotypic variability of LBD is striking, as it can manifest as the well-known disorder of Parkinson's disease without (PD) and with dementia (PDD), as well as DLB, MCI, REM sleep behavior disorder (RBD), pure autonomic failure (PAF), and other syndromes.

One biomarker which is both highly sensitive and specific for evolving LBD in the setting of dementia is DaTscan [Ioflupane (123I)] imaging, in which loss of functional dopaminergic neuron terminals in the striatum as assessed by DaTscan reflects underlying LBD in those with dementia and particularly dementia with Lewy bodies (DLB). DaTscan is the one of the first radiopharmaceutical agents available to detect DaT distribution within the brain. DaTscan imaging involves injection of the Ioflupane radioligand followed by imaging using a standard single photon emission computed tomography (SPECT) scanner. DaTscan provides visualization of the dopamine transporter (DaT) distribution within the striata (i.e., striatal uptake, or striatal signal) by SPECT imaging in patients presenting with symptoms or signs suggestive of dopaminergic neurodegeneration.

All DaTscan studies published to date have been conducted in centers outside of the US. DaTscan has not been studied in the syndrome of MCI, and minimally in corticobasal degeneration (CBD). Very little normative data exists in the aged population either.

The FDA-approved indication is to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS). In these patients, DaTscan may be used to help differentiate essential tremor from tremor due to Parkinsonian syndromes (such as idiopathic Parkinson's disease, multiple system atrophy and progressive supranuclear palsy). DaTscan will be used as an adjunct to other diagnostic evaluations. Identifying dopaminergic dysfunction is also important in other settings such as those with cognitive impairment with or without parkinsonism, and in subjects with REM sleep behavior disorder. The findings on DaTscan in subjects with these various disorders 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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Dementia
  • Parkinsonism
  • Mild Cognitive Impairment
  • REM Sleep Behavior Disorder
  • Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan)
    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.
  • Device: Single photon emission computed tomography (SPECT) scan
    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.
  • Experimental: Alzheimer's Disease
    Alzheimer's Disease
    Interventions:
    • Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan)
    • Device: Single photon emission computed tomography (SPECT) scan
  • Experimental: Dementia with Lewy Bodies
    Dementia with Lewy Bodies
    Interventions:
    • Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan)
    • Device: Single photon emission computed tomography (SPECT) scan
  • Experimental: Frontotemporal Dementia
    Frontotemporal Dementia
    Interventions:
    • Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan)
    • Device: Single photon emission computed tomography (SPECT) scan
  • Experimental: Parkinson's Disease
    Parkinson's Disease
    Interventions:
    • Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan)
    • Device: Single photon emission computed tomography (SPECT) scan
  • Experimental: Corticobasal Degeneration
    Corticobasal Degeneration
    Interventions:
    • Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan)
    • Device: Single photon emission computed tomography (SPECT) scan
  • Experimental: Essential Tremor
    Essential Tremor
    Interventions:
    • Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan)
    • Device: Single photon emission computed tomography (SPECT) scan
  • Experimental: Mild Cognitive Impairment
    Mild Cognitive Impairment
    Interventions:
    • Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan)
    • Device: Single photon emission computed tomography (SPECT) scan
  • Experimental: REM sleep behavior disorder
    REM sleep behavior disorder
    Interventions:
    • Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan)
    • Device: Single photon emission computed tomography (SPECT) scan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
120
November 2015
November 2015   (final data collection date for primary outcome measure)

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
Both
40 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01453127
11-001999
No
Bradley Boeve, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Bradley Boeve, MD Mayo Clinic
Mayo Clinic
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP