DementiaPhase 4NCT01453127
DaTSCAN Imaging in Aging and Neurodegenerative Disease
A Phase 4 study testing I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) and Single photon emission computed tomography (SPECT) scan in people with Dementia and Parkinsonism, run by Mayo Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Dementia, Parkinsonism, Mild Cognitive Impairment
- What is being tested?
- I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) and Single photon emission computed tomography (SPECT) scan
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
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.
- Being tested
- I-123 Ioflupane solution injection prior to SPECT scan (DaTscan), Single photon emission computed tomography (SPECT) scan
- Keywords
- dementia, parkinsonism, mild cognitive impairment, REM sleep behavior disorder
- Medical subject headings
- Dementia, Parkinsonian Disorders, Cognitive Dysfunction, REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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) scanDevice
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 group | Role | What they receive |
|---|---|---|
| Alzheimer's Disease | Experimental | Alzheimer's Disease Receives: Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan); Device: Single photon emission computed tomography (SPECT) scan |
| Dementia with Lewy Bodies | Experimental | Dementia with Lewy Bodies Receives: Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan); Device: Single photon emission computed tomography (SPECT) scan |
| Frontotemporal Dementia | Experimental | Frontotemporal Dementia Receives: Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan); Device: Single photon emission computed tomography (SPECT) scan |
| Parkinson's Disease | Experimental | Parkinson's Disease Receives: Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan); Device: Single photon emission computed tomography (SPECT) scan |
| Corticobasal Degeneration | Experimental | Corticobasal Degeneration Receives: Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan); Device: Single photon emission computed tomography (SPECT) scan |
| Essential Tremor | Experimental | Essential Tremor Receives: Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan); Device: Single photon emission computed tomography (SPECT) scan |
| Mild Cognitive Impairment | Experimental | Mild Cognitive Impairment Receives: Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan); Device: Single photon emission computed tomography (SPECT) scan |
| REM sleep behavior disorder | Experimental | REM sleep behavior disorder Receives: Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan); Device: Single photon emission computed tomography (SPECT) scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate the DaTscan findings with clinical diagnosis
The primary endpoint is to correlate the DaTscan findings with clinical diagnosis
Measured: Participants will be followed to 1-3 days after scan.
Secondary outcomes (1)
Safety of DaTscan imaging
The primary safety/tolerability endpoint relates to side effects associated with DaTscan imaging
Measured: Participants will be followed for 1-3 days after scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley Boeve, Mayo Clinic
- Investigators
- Bradley Boeve, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453127
- Sponsor's protocol ID
- 11-001999
- Status last verified
- Mar 2026
- First submitted
- 28 Sep 2011
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Arnaldi D, Mattioli P, Raffa S, Pardini M, Massa F, Iranzo A, Perissinotti A, Ninerola-Baizan A, Gaig C, Serradell M, Munoz-Lopetegi A, Maya G, Liguori C, Fernandes M, Placidi F, Chiaravalloti A, Sonka K, Dusek P, Zogala D, Trnka J, Boeve BF, Miyagawa T, Lowe VJ, Miyamoto T, Miyamoto M, Puligheddu M, Figorilli M, Serra A, Hu MT, Klein JC, Bes F, Kunz D, Cochen De Cock V, de Verbizier D, Plazzi G, Antelmi E, Terzaghi M, Bossert I, Kulcsarova K, Martino A, Giuliani A, Pagani M, Nobili F, Morbelli S; International REM Sleep Behavior Disorder Study Group. Presynaptic Dopaminergic Imaging Characterizes Patients with REM Sleep Behavior Disorder Due to Synucleinopathy. Ann Neurol. 2024 Jun;95(6):1178-1192. doi: 10.1002/ana.26902. Epub 2024 Mar 11.
PubMed 38466158Jung Y, Jordan LG 3rd, Lowe VJ, Kantarci K, Parisi JE, Dickson DW, Murray ME, Reichard RR, Ferman TJ, Jones DT, Graff-Radford J, Savica R, Machulda MM, Fields JA, Allen LA, Drubach DA, St Louis EK, Silber MH, Jack CR Jr, Knopman DS, Petersen RC, Boeve BF. Clinicopathological and 123I-FP-CIT SPECT correlations in patients with dementia. Ann Clin Transl Neurol. 2018 Jan 24;5(3):376-381. doi: 10.1002/acn3.521. eCollection 2018 Mar.
PubMed 29560382Chen Q, Lowe VJ, Boeve BF, Przybelski SA, Miyagawa T, Senjem ML, Jack CR Jr, Lesnick TG, Kremers WK, Fields JA, Min HK, Schwarz CG, Gunter JL, Graff-Radford J, Savica R, Knopman DS, Jones D, Ferman TJ, Graff-Radford NR, Petersen RC, Kantarci K. beta-Amyloid PET and 123I-FP-CIT SPECT in Mild Cognitive Impairment at Risk for Lewy Body Dementia. Neurology. 2021 Feb 22;96(8):e1180-e1189. doi: 10.1212/WNL.0000000000011454.
PubMed 33408148Maltais DD, Jordan LG, Min HK, Miyagawa T, Przybelski SA, Lesnick TG, Reichard RR, Dickson DW, Murray ME, Kantarci K, Boeve BF, Lowe VJ. Confirmation of 123I-FP-CIT SPECT Quantification Methods in Dementia with Lewy Bodies and Other Neurodegenerative Disorders. J Nucl Med. 2020 Nov;61(11):1628-1635. doi: 10.2967/jnumed.119.239418. Epub 2020 Mar 20.
PubMed 32198310Miyagawa T, Przybelski SA, Maltais D, Min HK, Jordan L, Lesnick TG, Chen Q, Graff-Radford J, Jones D, Savica R, Knopman D, Petersen R, Kremers WK, Forsberg LK, Fields JA, Ferman TJ, Allen L, Parisi J, Reichard RR, Murray M, Dickson D, Boeve BF, Kantarci K, Lowe VJ. The value of multimodal imaging with 123I-FP-CIT SPECT in differential diagnosis of dementia with Lewy bodies and Alzheimer's disease dementia. Neurobiol Aging. 2021 Mar;99:11-18. doi: 10.1016/j.neurobiolaging.2020.12.009. Epub 2020 Dec 15.
PubMed 33422890Arnaldi D, Chincarini A, Hu MT, Sonka K, Boeve B, Miyamoto T, Puligheddu M, De Cock VC, Terzaghi M, Plazzi G, Tachibana N, Morbelli S, Rolinski M, Dusek P, Lowe V, Miyamoto M, Figorilli M, Verbizier D, Bossert I, Antelmi E, Meli R, Barber TR, Trnka J, Miyagawa T, Serra A, Pizza F, Bauckneht M, Bradley KM, Zogala D, McGowan DR, Jordan L, Manni R, Nobili F. Dopaminergic imaging and clinical predictors for phenoconversion of REM sleep behaviour disorder. Brain. 2021 Feb 12;144(1):278-287. doi: 10.1093/brain/awaa365.
PubMed 33348363Diaz-Galvan P, Miyagawa T, Przybelski SA, Lesnick TG, Senjem ML, Jack CR Jr, Forsberg LK, Min HK, St Louis EK, Savica R, Fields JA, Benarroch EE, Lowe V, Petersen RC, Boeve BF, Kantarci K. Brain glucose metabolism and nigrostriatal degeneration in isolated rapid eye movement sleep behaviour disorder. Brain Commun. 2023 Feb 2;5(1):fcad021. doi: 10.1093/braincomms/fcad021. eCollection 2023.
PubMed 36844148
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DaTSCAN Imaging in Aging and Neurodegenerative Disease
- ClinicalTrials.gov ID
- NCT01453127
- Acronym / sponsor ID
- 11-001999
- Keywords
- dementia, parkinsonism, mild cognitive impairment, REM sleep behavior disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's Disease | Experimental | Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan), Device: Single photon emission computed tomography (SPECT) scanAlzheimer's Disease |
| Dementia with Lewy Bodies | Experimental | Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan), Device: Single photon emission computed tomography (SPECT) scanDementia with Lewy Bodies |
| Frontotemporal Dementia | Experimental | Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan), Device: Single photon emission computed tomography (SPECT) scanFrontotemporal Dementia |
| Parkinson's Disease | Experimental | Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan), Device: Single photon emission computed tomography (SPECT) scanParkinson's Disease |
| Corticobasal Degeneration | Experimental | Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan), Device: Single photon emission computed tomography (SPECT) scanCorticobasal Degeneration |
| Essential Tremor | Experimental | Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan), Device: Single photon emission computed tomography (SPECT) scanEssential Tremor |
| Mild Cognitive Impairment | Experimental | Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan), Device: Single photon emission computed tomography (SPECT) scanMild Cognitive Impairment |
| REM sleep behavior disorder | Experimental | Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan), Device: Single photon emission computed tomography (SPECT) scanREM sleep behavior disorder |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Alzheimer's Disease, Corticobasal Degeneration, Dementia with Lewy Bodies, Essential Tremor, Frontotemporal Dementia, Mild Cognitive Impairment, Parkinson's Disease, REM sleep behavior disorder |
| Single photon emission computed tomography (SPECT) scanSingle-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. | Device | Alzheimer's Disease, Corticobasal Degeneration, Dementia with Lewy Bodies, Essential Tremor, Frontotemporal Dementia, Mild Cognitive Impairment, Parkinson's Disease, REM sleep behavior disorder |
Primary outcome
Correlate the DaTscan findings with clinical diagnosis
Time frame: Participants will be followed to 1-3 days after scan.
The primary endpoint is to correlate the DaTscan findings with clinical diagnosis
1 secondary outcome
Safety of DaTscan imaging
Time frame: Participants will be followed for 1-3 days after scan.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 38466158Arnaldi D, Mattioli P, Raffa S, Pardini M, Massa F, Iranzo A, Perissinotti A, Ninerola-Baizan A, Gaig C, Serradell M, Munoz-Lopetegi A, Maya G, Liguori C, Fernandes M, Placidi F, Chiaravalloti A, Sonka K, Dusek P, Zogala D, Trnka J, Boeve BF, Miyagawa T, Lowe VJ, Miyamoto T, Miyamoto M, Puligheddu M, Figorilli M, Serra A, Hu MT, Klein JC, Bes F, Kunz D, Cochen De Cock V, de Verbizier D, Plazzi G, Antelmi E, Terzaghi M, Bossert I, Kulcsarova K, Martino A, Giuliani A, Pagani M, Nobili F, Morbelli S; International REM Sleep Behavior Disorder Study Group. Presynaptic Dopaminergic Imaging Characterizes Patients with REM Sleep Behavior Disorder Due to Synucleinopathy. Ann Neurol. 2024 Jun;95(6):1178-1192. doi: 10.1002/ana.26902. Epub 2024 Mar 11.
- Results publication: PubMed 29560382Jung Y, Jordan LG 3rd, Lowe VJ, Kantarci K, Parisi JE, Dickson DW, Murray ME, Reichard RR, Ferman TJ, Jones DT, Graff-Radford J, Savica R, Machulda MM, Fields JA, Allen LA, Drubach DA, St Louis EK, Silber MH, Jack CR Jr, Knopman DS, Petersen RC, Boeve BF. Clinicopathological and 123I-FP-CIT SPECT correlations in patients with dementia. Ann Clin Transl Neurol. 2018 Jan 24;5(3):376-381. doi: 10.1002/acn3.521. eCollection 2018 Mar.
- Results publication: PubMed 33408148Chen Q, Lowe VJ, Boeve BF, Przybelski SA, Miyagawa T, Senjem ML, Jack CR Jr, Lesnick TG, Kremers WK, Fields JA, Min HK, Schwarz CG, Gunter JL, Graff-Radford J, Savica R, Knopman DS, Jones D, Ferman TJ, Graff-Radford NR, Petersen RC, Kantarci K. beta-Amyloid PET and 123I-FP-CIT SPECT in Mild Cognitive Impairment at Risk for Lewy Body Dementia. Neurology. 2021 Feb 22;96(8):e1180-e1189. doi: 10.1212/WNL.0000000000011454.
- Results publication: PubMed 32198310Maltais DD, Jordan LG, Min HK, Miyagawa T, Przybelski SA, Lesnick TG, Reichard RR, Dickson DW, Murray ME, Kantarci K, Boeve BF, Lowe VJ. Confirmation of 123I-FP-CIT SPECT Quantification Methods in Dementia with Lewy Bodies and Other Neurodegenerative Disorders. J Nucl Med. 2020 Nov;61(11):1628-1635. doi: 10.2967/jnumed.119.239418. Epub 2020 Mar 20.
- Results publication: PubMed 33422890Miyagawa T, Przybelski SA, Maltais D, Min HK, Jordan L, Lesnick TG, Chen Q, Graff-Radford J, Jones D, Savica R, Knopman D, Petersen R, Kremers WK, Forsberg LK, Fields JA, Ferman TJ, Allen L, Parisi J, Reichard RR, Murray M, Dickson D, Boeve BF, Kantarci K, Lowe VJ. The value of multimodal imaging with 123I-FP-CIT SPECT in differential diagnosis of dementia with Lewy bodies and Alzheimer's disease dementia. Neurobiol Aging. 2021 Mar;99:11-18. doi: 10.1016/j.neurobiolaging.2020.12.009. Epub 2020 Dec 15.
- Results publication: PubMed 33348363Arnaldi D, Chincarini A, Hu MT, Sonka K, Boeve B, Miyamoto T, Puligheddu M, De Cock VC, Terzaghi M, Plazzi G, Tachibana N, Morbelli S, Rolinski M, Dusek P, Lowe V, Miyamoto M, Figorilli M, Verbizier D, Bossert I, Antelmi E, Meli R, Barber TR, Trnka J, Miyagawa T, Serra A, Pizza F, Bauckneht M, Bradley KM, Zogala D, McGowan DR, Jordan L, Manni R, Nobili F. Dopaminergic imaging and clinical predictors for phenoconversion of REM sleep behaviour disorder. Brain. 2021 Feb 12;144(1):278-287. doi: 10.1093/brain/awaa365.
- Results publication: PubMed 36844148Diaz-Galvan P, Miyagawa T, Przybelski SA, Lesnick TG, Senjem ML, Jack CR Jr, Forsberg LK, Min HK, St Louis EK, Savica R, Fields JA, Benarroch EE, Lowe V, Petersen RC, Boeve BF, Kantarci K. Brain glucose metabolism and nigrostriatal degeneration in isolated rapid eye movement sleep behaviour disorder. Brain Commun. 2023 Feb 2;5(1):fcad021. doi: 10.1093/braincomms/fcad021. eCollection 2023.
- Mayo Clinic Clinical Trials - Lewy Body DiseaseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bradley Boeve, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) and Single photon emission computed tomography (SPECT) scan in people with Dementia and Parkinsonism, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlate the DaTscan findings with clinical diagnosis (time frame: Participants will be followed to 1-3 days after scan.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01453127, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.