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Tau Imaging With JNJ067

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ClinicalTrials.gov Identifier: NCT03926702
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, Berkeley

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 18, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

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


Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926702


Contacts
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Contact: William Jagust, MD 510-643-6537 jagust@berkeley.edu
Contact: Kris Norton, CNMT 510-486-7562 khnorton@lbl.gov

Locations
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United States, California
University of California, Berkeley Recruiting
Berkeley, California, United States, 94709
Contact: Tacie Moskowitz    610-416-9882    tacie.moskowitz@gmail.com   
Sponsors and Collaborators
University of California, Berkeley
University of California, San Francisco
More Information
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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: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Possibility to share PET data

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Supranuclear Palsy, Progressive
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
 Basal Ganglia Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Paralysis
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action