A Phase 4 interventional study of I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) and Single photon emission computed tomography (SPECT) scan in Dementia, Parkinsonism and Mild Cognitive Impairment, sponsored by Mayo Clinic. Enrolling by invitation at 1 site in United States. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Diagnostic
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.
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.
Most 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. A subset of subjects will undergo a 2nd DaTscan at least 1 year after the initial scan was performed to determine if changes over time provide any prognostic information.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's planned enrollment of 500 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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Exclusion Criteria:
Active medical disorder that could preclude participation in this protocol
Alzheimer's Disease
Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) · Device: Single photon emission computed tomography (SPECT) scan
Dementia with Lewy Bodies
Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) · Device: Single photon emission computed tomography (SPECT) scan
Frontotemporal Dementia
Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) · Device: Single photon emission computed tomography (SPECT) scan
Parkinson's Disease
Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) · Device: Single photon emission computed tomography (SPECT) scan
Corticobasal Degeneration
Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) · Device: Single photon emission computed tomography (SPECT) scan
Essential Tremor
Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) · Device: Single photon emission computed tomography (SPECT) scan
Mild Cognitive Impairment
Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) · Device: Single photon emission computed tomography (SPECT) scan
REM sleep behavior disorder
Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) · Device: Single photon emission computed tomography (SPECT) scan
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)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.
Correlate the DaTscan findings with clinical diagnosis
The primary endpoint is to correlate the DaTscan findings with clinical diagnosis
Time frame: Participants will be followed to 1-3 days after scan.
Safety of DaTscan imaging
The primary safety/tolerability endpoint relates to side effects associated with DaTscan imaging
Time frame: Participants will be followed for 1-3 days after scan.
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