跳至主要内容
临床试验/NCT01453127
NCT01453127Enrolling By Invitation4 期

DaTSCAN Imaging in Aging and Neurodegenerative Disease

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2011年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
Enrolling By Invitation
发起方
Mayo Clinic
入组人数
500
试验地点
1
主要终点
Correlate the DaTscan findings with clinical diagnosis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Alzheimer's Disease

Experimental

Alzheimer's Disease

干预措施: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) (Drug)

Alzheimer's Disease

Experimental

Alzheimer's Disease

干预措施: Single photon emission computed tomography (SPECT) scan (Device)

Dementia with Lewy Bodies

Experimental

Dementia with Lewy Bodies

干预措施: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) (Drug)

Dementia with Lewy Bodies

Experimental

Dementia with Lewy Bodies

干预措施: Single photon emission computed tomography (SPECT) scan (Device)

Frontotemporal Dementia

Experimental

Frontotemporal Dementia

干预措施: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) (Drug)

Frontotemporal Dementia

Experimental

Frontotemporal Dementia

干预措施: Single photon emission computed tomography (SPECT) scan (Device)

Parkinson's Disease

Experimental

Parkinson's Disease

干预措施: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) (Drug)

Parkinson's Disease

Experimental

Parkinson's Disease

干预措施: Single photon emission computed tomography (SPECT) scan (Device)

Corticobasal Degeneration

Experimental

Corticobasal Degeneration

干预措施: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) (Drug)

Corticobasal Degeneration

Experimental

Corticobasal Degeneration

干预措施: Single photon emission computed tomography (SPECT) scan (Device)

Essential Tremor

Experimental

Essential Tremor

干预措施: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) (Drug)

Essential Tremor

Experimental

Essential Tremor

干预措施: Single photon emission computed tomography (SPECT) scan (Device)

Mild Cognitive Impairment

Experimental

Mild Cognitive Impairment

干预措施: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) (Drug)

Mild Cognitive Impairment

Experimental

Mild Cognitive Impairment

干预措施: Single photon emission computed tomography (SPECT) scan (Device)

REM sleep behavior disorder

Experimental

REM sleep behavior disorder

干预措施: I-123 Ioflupane solution injection prior to SPECT scan (DaTscan) (Drug)

REM sleep behavior disorder

Experimental

REM sleep behavior disorder

干预措施: Single photon emission computed tomography (SPECT) scan (Device)

结局指标

主要结局

Correlate the DaTscan findings with clinical diagnosis

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

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

次要结局

  • Safety of DaTscan imaging(Participants will be followed for 1-3 days after scan.)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bradley Boeve

Principal Investigator

Mayo Clinic

研究点 (1)

Loading locations...

相似试验