Tau Imaging With JNJ067

NCT03926702 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 073H040
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Mild Cognitive Impairment; Progressive Supranuclear Palsy

Outcome Measures

Primary Outcomes (1)

• Positron-emission tomography (PET) scan results

  PET standard uptake value ratio (SUVR) data

  3 hours

Study Arms (1)

Radiopharmaceutical administration

EXPERIMENTAL

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

Drug: Radiopharmaceuticals

Interventions

Radiopharmaceuticals DRUG

All subjects will receive radiopharmaceutical for positron-emission tomography (PET) scan.

Radiopharmaceutical administration

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Berkeley: lead
• University of California, San Francisco: collaborator

Study Sites (1)

University of California, Berkeley

Berkeley, California, 94709, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Supranuclear Palsy, Progressive

Interventions

Radiopharmaceuticals

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Molecular Mechanisms of Pharmacological Action; Indicators and Reagents; Laboratory Chemicals; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 24, 2019
• Study Start: June 18, 2019
• Primary Completion: January 6, 2021
• Study Completion: January 6, 2021
• Last Updated: August 31, 2022

Record last verified: 2022-08

Locations

US (1)