Tau Imaging With JNJ067

Brief Title

Tau Imaging With JNJ067

Official Title

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.
    

Study Phase

Early Phase 1

Study Type

Interventional

Primary Outcome

Positron-emission tomography (PET) scan results

Condition

Alzheimer Disease

Intervention

Radiopharmaceuticals

Study Arms / Comparison Groups

 Radiopharmaceutical administration

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

18

Start Date

June 18, 2019

Completion Date

January 6, 2021

Primary Completion Date

January 6, 2021

Eligibility 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
      

Gender

All

Ages

50 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

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Location Countries

United States

Location Countries

United States

NCT ID

NCT03926702

Organization ID

073H040

Responsible Party

Sponsor

Study Sponsor

University of California, Berkeley

Collaborators

 University of California, San Francisco

Study Sponsor

, , 

Verification Date

August 2022