DaTSCAN Imaging in Aging and Neurodegenerative Disease - Full Text View

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	Drug: DaTscan Device: Single photon emission computed tomography (SPECT) scan	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: 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:

Genetics Home Reference related topics: Perry syndrome

MedlinePlus related topics: Alzheimer's Disease Degenerative Nerve Diseases Dementia Lewy Body Disease Mild Cognitive Impairment Nuclear Scans Parkinson's Disease Tremor

Drug Information available for: Ioflupane I 123

U.S. FDA Resources

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:	100
Study Start Date:	October 2011
Estimated Study Completion Date:	November 2014
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Alzheimer's Disease Alzheimer's Disease	Drug: DaTscan DaTscan is a solution of I-123 Ioflupane 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: DaTscan DaTscan is a solution of I-123 Ioflupane 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: DaTscan DaTscan is a solution of I-123 Ioflupane 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: DaTscan DaTscan is a solution of I-123 Ioflupane 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: Progressive Supranuclear Palsy Progressive Supranuclear Palsy	Drug: DaTscan DaTscan is a solution of I-123 Ioflupane 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: Multiple System Atrophy Multiple System Atrophy	Drug: DaTscan DaTscan is a solution of I-123 Ioflupane 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: DaTscan DaTscan is a solution of I-123 Ioflupane 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: DaTscan DaTscan is a solution of I-123 Ioflupane 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: DaTscan DaTscan is a solution of I-123 Ioflupane 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

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 1, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Dementia
Parkinsonian Disorders
Cognition Disorders
Neurodegenerative Diseases
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Basal Ganglia Diseases
Movement Disorders

ClinicalTrials.gov processed this record on May 16, 2013