An Early Phase 1 interventional study of Radiopharmaceuticals in Alzheimer Disease, Mild Cognitive Impairment and Progressive Supranuclear Palsy, sponsored by University of California, Berkeley. Completed at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-31.
Sponsored by University of California, Berkeley · Early Phase 1, Interventional, and Basic science
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.
3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.
This study's enrollment of 18 is below the median of 68 across 2,861 interventional studies indexed under Alzheimer Disease.
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Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
All participants receive radiopharmaceutical for positron-emission tomography (PET) study.
Drug: Radiopharmaceuticals
All subjects will receive radiopharmaceutical for positron-emission tomography (PET) scan.
Positron-emission tomography (PET) scan results
PET standard uptake value ratio (SUVR) data
Time frame: 3 hours
Plan to share: Undecided — Possibility to share PET data
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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