Alzheimer DiseaseEarly Phase 1NCT03926702
Tau Imaging With JNJ067
A Early Phase 1 study testing Radiopharmaceuticals in people with Alzheimer Disease and Mild Cognitive Impairment, run by University of California, Berkeley at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment, Progressive Supranuclear Palsy
- What is being tested?
- Radiopharmaceuticals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2019to 6 Jan 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Berkeley
Berkeley, California, 94709
About this study
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.
- Being tested
- Radiopharmaceuticals
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiopharmaceuticalsDrug
All subjects will receive radiopharmaceutical for positron-emission tomography (PET) scan.
| Study group | Role | What they receive |
|---|---|---|
| Radiopharmaceutical administration | Experimental | All participants receive radiopharmaceutical for positron-emission tomography (PET) study. Receives: Drug: Radiopharmaceuticals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positron-emission tomography (PET) scan results
PET standard uptake value ratio (SUVR) data
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start18 Jun 2019
- Primary completion6 Jan 2021
- Study completion6 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926702
- Sponsor's protocol ID
- 073H040
- Status last verified
- Aug 2022
- First submitted
- 22 Apr 2019
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Possibility to share PET data
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tau Imaging With JNJ067
- ClinicalTrials.gov ID
- NCT03926702
- Acronym / sponsor ID
- 073H040
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 6 Jan 2021 (actual)
- Study completion
- 6 Jan 2021 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Radiopharmaceutical administration | Experimental | Drug: RadiopharmaceuticalsAll participants receive radiopharmaceutical for positron-emission tomography (PET) study. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiopharmaceuticalsAll subjects will receive radiopharmaceutical for positron-emission tomography (PET) scan. | Drug | Radiopharmaceutical administration |
Primary outcome
Positron-emission tomography (PET) scan results
Time frame: 3 hours
PET standard uptake value ratio (SUVR) data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Individual participant dataSharing planned: Undecided. Possibility to share PET data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Radiopharmaceuticals in people with Alzheimer Disease and Mild Cognitive Impairment, run by University of California, Berkeley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positron-emission tomography (PET) scan results (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.