Tau Imaging With JNJ067

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 Overview

• Status: Completed
• Conditions: Alzheimer Disease; Mild Cognitive Impairment; Progressive Supranuclear Palsy
• Intervention / Treatment: Drug: Radiopharmaceuticals

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94709
      • University of California, Berkeley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positron-emission tomography (PET) scan results	PET standard uptake value ratio (SUVR) data	3 hours

Collaborators and Investigators

• Sponsor: University of California, Berkeley
• Collaborators: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 18, 2019
• Primary Completion (ACTUAL): January 6, 2021
• Study Completion (ACTUAL): January 6, 2021

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 22, 2019
• First Posted (ACTUAL): April 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Neurocognitive Disorders; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Cranial Nerve Diseases; Ocular Motility Disorders; Paralysis; Ophthalmoplegia; Alzheimer Disease; Cognitive Dysfunction; Supranuclear Palsy, Progressive; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals
• Other Study ID Numbers: 073H040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Possibility to share PET data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No