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
  Purpose

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.


Condition Intervention Phase
Dementia
Parkinsonism
Mild Cognitive Impairment
REM Sleep Behavior Disorder
Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan)
Device: Single photon emission computed tomography (SPECT) scan
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: DaTSCAN Imaging in Aging and Neurodegenerative Disease

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 120
Study Start Date: October 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alzheimer's Disease
Alzheimer's Disease
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: Dementia with Lewy Bodies
Dementia with Lewy Bodies
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: Frontotemporal Dementia
Frontotemporal Dementia
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: Parkinson's Disease
Parkinson's Disease
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: Corticobasal Degeneration
Corticobasal Degeneration
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: Essential Tremor
Essential Tremor
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: Mild Cognitive Impairment
Mild Cognitive Impairment
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: REM sleep behavior disorder
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453127

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Bradley Boeve, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Bradley Boeve, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01453127     History of Changes
Other Study ID Numbers: 11-001999
Study First Received: September 28, 2011
Last Updated: April 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
dementia
parkinsonism
mild cognitive impairment
REM sleep behavior disorder

Additional relevant MeSH terms:
Mental Disorders
Dementia
Parkinsonian Disorders
Cognition Disorders
Neurodegenerative Diseases
REM Sleep Behavior Disorder
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Basal Ganglia Diseases
Movement Disorders
REM Sleep Parasomnias
Parasomnias
Sleep Disorders

ClinicalTrials.gov processed this record on July 24, 2014