DaTSCAN Imaging in Aging and Neurodegenerative Disease

NCT01453127 | Enrolling By Invitation Phase 4 FDA Device

• 1 other identifier: 11-001999
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Dementia; Parkinsonism; REM Sleep Behavior Disorder; Mild Cognitive Impairment

Keywords

dementia; parkinsonism; mild cognitive impairment; REM sleep behavior disorder

Outcome Measures

Primary Outcomes (1)

• Correlate the DaTscan findings with clinical diagnosis

  The primary endpoint is to correlate the DaTscan findings with clinical diagnosis

  Participants will be followed to 1-3 days after scan.

Secondary Outcomes (1)

• Safety of DaTscan imaging

  Participants will be followed for 1-3 days after scan.

Study Arms (8)

Alzheimer's Disease

EXPERIMENTAL

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

EXPERIMENTAL

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

EXPERIMENTAL

Frontotemporal Dementia

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

Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan); Device: Single photon emission computed tomography (SPECT) scan

Corticobasal Degeneration

EXPERIMENTAL

Corticobasal Degeneration

Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan); Device: Single photon emission computed tomography (SPECT) scan

Essential Tremor

EXPERIMENTAL

Essential Tremor

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

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

Drug: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan); Device: Single photon emission computed tomography (SPECT) scan

Interventions

Single photon emission computed tomography (SPECT) scan DEVICE

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.

Alzheimer's Disease; Corticobasal Degeneration; Dementia with Lewy Bodies; Essential Tremor; Frontotemporal Dementia; Mild Cognitive Impairment; Parkinson's Disease; REM sleep behavior disorder

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.

Alzheimer's Disease; Corticobasal Degeneration; Dementia with Lewy Bodies; Essential Tremor; Frontotemporal Dementia; Mild Cognitive Impairment; Parkinson's Disease; REM sleep behavior disorder

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (7)

• 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.

  PMID: 38466158 BACKGROUND

• Jung 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.

  PMID: 29560382 RESULT

• Chen 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.

  PMID: 33408148 RESULT

• Maltais 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.

  PMID: 32198310 RESULT

• Miyagawa 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.

  PMID: 33422890 RESULT

• Arnaldi 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.

  PMID: 33348363 RESULT

• Diaz-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.

  PMID: 36844148 RESULT

Related Links

• Mayo Clinic Clinical Trials - Lewy Body Disease

MeSH Terms

Conditions

Dementia; Parkinsonian Disorders; Cognitive Dysfunction; REM Sleep Behavior Disorder

Interventions

ioflupane; Tomography, Emission-Computed, Single-Photon; Radionuclide Imaging

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Basal Ganglia Diseases; Movement Disorders; Cognition Disorders; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Bradley Boeve, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2011
• First Posted: October 17, 2011
• Study Start: October 1, 2011
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

US (1)