This website is for US healthcare professionals

close-icon

Log In to Bolder Science

or

Don't have an account? Sign Up

close-icon

Please enter your email address.

You will receive a link to create a new password via email.

Log In

close-icon

Create an Account

or
  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number
close-icon

Welcome and thank you for creating an account!

At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

Condition Categories

Condition categories are pulled directly from ClinicalTrials.gov. Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

Tau Imaging With JNJ067

  • Clinicaltrials.gov identifier

    NCT03926702

  • Recruitment Status

    Active, not recruiting

  • First Posted

    April 24, 2019

  • Last update posted

    March 24, 2020

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:Mild Cognitive Impairment
    Progressive Supranuclear Palsy
    Alzheimer Disease
  • Intervention/Treatment: Drug: Radiopharmaceuticals
  • Phase: Early Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 18 participants
  • 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 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

  • 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

Contacts

Locations

United States, California
University of California, Berkeley
Berkeley

Sponsors and Collaborators

University of California, Berkeley

University of California, San Francisco

More Information

  • Responsible Party: University of California, Berkeley
  • ClinicalTrials.gov Identifier: NCT03926702 History of Changes
  • Other Study ID Numbers: 073H040
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: March 24, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Undecided
  • Plan Description: Possibility to share PET data
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Alzheimer Disease
    Supranuclear Palsy, Progressive
    Cognitive Dysfunction