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临床试验/NCT03926702
NCT03926702已完成早期 1 期

Tau Imaging With JNJ067

University of California, Berkeley1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2019年6月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
18
试验地点
1
主要终点
Positron-emission tomography (PET) scan results

研究概览

简要总结

This protocol is designed to assess the utility of a new positron emission tomography (PET) radiopharmaceutical to image tau, [18F] JNJ067, invented by Janssen Pharmaceutical companies of Johnson & Johnson. To date, the radiopharmaceutical has been used in a small group of patients and controls (<20). The study plans to expand the range and number of subjects, to examine a total of 18 participants including controls and patients with Alzheimer's disease (AD) and other dementias. All patients will be recruited from the University of California, San Francisco (UCSF) Memory and Aging Center (MAC) and controls will be recruited from the University of California, Berkeley Aging Cohort Study (BACS). Patients will undergo a multidisciplinary clinical evaluation for diagnosis and a cognitive assessment at the MAC; controls will undergo the usual BACS cognitive assessment performed on the Berkeley campus. Following these evaluations UCSF subjects will undergo magnetic resonance imaging (MRI) scanning at the UCSF Neuroimaging Center and blood sampling for genetic testing also at UCSF, and BACS subjects will undergo an MRI at the University of California Berkeley 3T Brain Imaging Center (in Li Ka Shing hall on the Berkeley campus) and blood sampling for genetic testing at the time of the PET scan.

All subjects will come to Lawrence Berkeley National Law (LBNL) where they will have, on the same day, a C-11 Pittsburgh compound B (PIB) PET scan to measure brain amyloid, and an F-18 JNJ067 PET scan to measure brain tau. These scans will be examined and analyzed by LBNL staff, and data will be processed to examine basic questions about the quantitative behavior of JNJ067. Scan results will not be returned to control subjects, but physicians at UCSF will receive scan results on MAC patients and will share results with participants.

As part of this protocol, the investigators also plan to share the acquired data widely. All data will be de-identified. Data will be shared with the inventors (Janssen/Johnson & Johnson) as well as other scientists worldwide. As this is a new radio tracer, the investigators anticipate that there will be interest in seeing the actual data to answer questions about uptake and application of the method in future studies in many different laboratories. Shared data will include PET scans, MRI scans, genetic testing, and neuropsychological results.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Healthy Volunteers: Subjects must be aged 50 and over. These individuals will all be of good general medical health with no neurological diseases and capable of providing informed consent.
  • Patients: Subjects must be aged 50 and over. Patients will meet diagnostic criteria at UCSF for Alzheimer's disease (AD), mild cognitive impairment (MCI), or progressive supranuclear palsy (PSP).

排除标准

  • Any medical contraindications to an MRI scan
  • A pacemaker
  • Metal clips in brain or tattoos above neck
  • Metallic implants or shrapnel in body
  • Any body jewelry or piercings that are not removable
  • A history of claustrophobia
  • A known major systemic disease
  • A history of a psychiatric disorder
  • A history of substance abuse (prescription or non-prescription) within the past 5 years
  • A current weight of less than 45 kilograms (100 pounds)
  • Difficulty in urinating or emptying the bladder
  • Under age 50
  • Participating in an experimental radiotracer study
  • Subjects must be fluent English speakers

研究组 & 干预措施

Radiopharmaceutical administration

Experimental

All participants receive radiopharmaceutical for positron-emission tomography (PET) study.

干预措施: Radiopharmaceuticals (Drug)

结局指标

主要结局

Positron-emission tomography (PET) scan results

时间窗: 3 hours

PET standard uptake value ratio (SUVR) data

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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