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出境医 / 临床实验 / Tau Imaging With JNJ067

Tau Imaging With JNJ067

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Mild Cognitive Impairment Progressive Supranuclear Palsy Drug: Radiopharmaceuticals Early Phase 1

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will undergo the same evaluation, which includes screening, cognitive assessment, magnetic resonance imaging scanning (MRI) of the brain, and genetic testing for Apolipoprotein E. Subsequently all subjects will undergo positron-emission tomography (PET) scanning with C-11 PIB (Pittsburgh compound B) for amyloid detection, and JNJ067 for tau detection.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Tau Imaging With JNJ067
Actual Study Start Date : June 18, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Radiopharmaceutical administration
All participants receive radiopharmaceutical for positron-emission tomography (PET) study.
Drug: Radiopharmaceuticals
All subjects will receive radiopharmaceutical for positron-emission tomography (PET) scan.

Outcome Measures
Primary Outcome Measures :
  1. Positron-emission tomography (PET) scan results [ Time Frame: 3 hours ]
    PET standard uptake value ratio (SUVR) data


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
Contacts and Locations

Locations
Layout table for location information
United States, California
University of California, Berkeley
Berkeley, California, United States, 94709
Sponsors and Collaborators
University of California, Berkeley
University of California, San Francisco
Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE June 18, 2019
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
Positron-emission tomography (PET) scan results [ Time Frame: 3 hours ]
PET standard uptake value ratio (SUVR) data
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
PET scan results [ Time Frame: 3 hours ]
PET SUVR data
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tau Imaging With JNJ067
Official Title  ICMJE Tau Imaging With JNJ067
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
All participants will undergo the same evaluation, which includes screening, cognitive assessment, magnetic resonance imaging scanning (MRI) of the brain, and genetic testing for Apolipoprotein E. Subsequently all subjects will undergo positron-emission tomography (PET) scanning with C-11 PIB (Pittsburgh compound B) for amyloid detection, and JNJ067 for tau detection.
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Alzheimer Disease
  • Mild Cognitive Impairment
  • Progressive Supranuclear Palsy
Intervention  ICMJE Drug: Radiopharmaceuticals
All subjects will receive radiopharmaceutical for positron-emission tomography (PET) scan.
Study Arms  ICMJE Experimental: Radiopharmaceutical administration
All participants receive radiopharmaceutical for positron-emission tomography (PET) study.
Intervention: Drug: Radiopharmaceuticals
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 22, 2019)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03926702
Other Study ID Numbers  ICMJE 073H040
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Possibility to share PET data
Responsible Party University of California, Berkeley
Study Sponsor  ICMJE University of California, Berkeley
Collaborators  ICMJE University of California, San Francisco
Investigators  ICMJE Not Provided
PRS Account University of California, Berkeley
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP