Tau Imaging With JNJ067

Alzheimer Disease Clinical Trial

Official title:

Tau Imaging With JNJ067

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03926702
• Other study ID #: 073H040
• Status: Completed
• Phase: Early Phase 1
• Start date: June 18, 2019
• Est. completion date: January 6, 2021

Study information

• Verified date: August 2022
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 6, 2021
• Est. primary completion date: January 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment
• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Intervention

Drug:
• Radiopharmaceuticals
All subjects will receive radiopharmaceutical for positron-emission tomography (PET) scan.

Locations

Country	Name	City	State
United States	University of California, Berkeley	Berkeley	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Berkeley	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positron-emission tomography (PET) scan results	PET standard uptake value ratio (SUVR) data	3 hours