Tau Imaging With JNJ067
Primary Purpose
Alzheimer Disease, Mild Cognitive Impairment, Progressive Supranuclear Palsy
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Radiopharmaceuticals
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer Disease
Eligibility 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
Sites / Locations
- University of California, Berkeley
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiopharmaceutical administration
Arm Description
All participants receive radiopharmaceutical for positron-emission tomography (PET) study.
Outcomes
Primary Outcome Measures
Positron-emission tomography (PET) scan results
PET standard uptake value ratio (SUVR) data
Secondary Outcome Measures
Full Information
NCT ID
NCT03926702
First Posted
April 22, 2019
Last Updated
August 29, 2022
Sponsor
University of California, Berkeley
Collaborators
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT03926702
Brief Title
Tau Imaging With JNJ067
Official Title
Tau Imaging With JNJ067
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 18, 2019 (Actual)
Primary Completion Date
January 6, 2021 (Actual)
Study Completion Date
January 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Berkeley
Collaborators
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Mild Cognitive Impairment, Progressive Supranuclear Palsy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiopharmaceutical administration
Arm Type
Experimental
Arm Description
All participants receive radiopharmaceutical for positron-emission tomography (PET) study.
Intervention Type
Drug
Intervention Name(s)
Radiopharmaceuticals
Intervention Description
All subjects will receive radiopharmaceutical for positron-emission tomography (PET) scan.
Primary Outcome Measure Information:
Title
Positron-emission tomography (PET) scan results
Description
PET standard uptake value ratio (SUVR) data
Time Frame
3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University of California, Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94709
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Possibility to share PET data
Learn more about this trial
Tau Imaging With JNJ067
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