Tau Imaging With JNJ067
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03926702|
Recruitment Status : Active, not recruiting
First Posted : April 24, 2019
Last Update Posted : March 24, 2020
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 Type :||Interventional (Clinical Trial)|
|Actual 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 2021|
|Estimated Study Completion Date :||January 2021|
Experimental: Radiopharmaceutical administration
All participants receive radiopharmaceutical for positron-emission tomography (PET) study.
All subjects will receive radiopharmaceutical for positron-emission tomography (PET) scan.
- Positron-emission tomography (PET) scan results [ Time Frame: 3 hours ]PET standard uptake value ratio (SUVR) data
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
|United States, California|
|University of California, Berkeley|
|Berkeley, California, United States, 94709|