Cognitive DeclinePhase 1NCT03052972
Flortaucipir 18F PET Imaging in BIOCARD Study
A Phase 1 study testing Flortaucipir F18 and Brain PET scan in people with Cognitive Decline, run by Avid Radiopharmaceuticals at 1 site in United States.
Trial summary
This study is designed to assess the imaging characteristics of Flortaucipir (18F-AV-1451) in subjects who participated in the Biomarkers of Cognitive Decline Among Normal Individuals (BIOCARD) study at Johns Hopkins University. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- Flortaucipir F18 and Brain PET scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2017to 17 Aug 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Males or females that have provided consent and are currently enrolled in BIOCARD study
- Ability to tolerate PET scan procedures
- Ability to provide informed consent for study procedures
Who cannot join
- Has condition(s) that could augment risk to participant or compromise ability to tolerate experimental procedures or interfere with analysis of the study data as determined by the investigator
- Has a history of risk factors for Torsades de Pointes or taking medications known to cause QT prolongation.
- Has electrocardiogram acquired prior to initial flortaucipir scan that clinically contradicts subject's participation in the study as determined by the investigator. Bazett's corrected QT (QTcB) interval must be assessed and not exceed accepted values (458 msec in males, 474 msec in females).
- Females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraceptive methods.
- Has hypersensitivity to flortaucipir
- Has a currently clinically significant infectious disease, endocrine/metabolic disease, pulmonary/renal/hepatic impairment, or cancer that could impact study participation or scan results in the opinion of the investigator.
- Has a non-study related radiopharmaceutical imaging/treatment procedure within seven days prior to flortaucipir imaging visit.
- Is unsuitable for a study of this type in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flortaucipir (18F) PET Imaging in the BIOCARD Study
This study is designed to assess the imaging characteristics of Flortaucipir (18F-AV-1451) in subjects who participated in the Biomarkers of Cognitive Decline Among Normal Individuals (BIOCARD) study at Johns Hopkins University.
- Conditions
- Cognitive Decline
- Being tested
- Flortaucipir F18, Brain PET scan
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flortaucipir F18Drug
Also called 18F-AV-1451, [F-18]T807, LY3191748, Tauvid
370 megabecquerel (MBq)(10 millicurie [mCi]) single dose
Brain PET scanProcedure or surgery
positron emission tomography (PET) scan of the brain
| Study group | Role | What they receive |
|---|---|---|
| Amyloid Positive | Experimental | Clinically normal amyloid positive subjects from BIOCARD study receiving a flortaucipir PET scan Receives: Drug: Flortaucipir F18; Procedure: Brain PET scan |
| Amyloid Negative | Experimental | Clinically normal amyloid negative subjects from BIOCARD study receiving a flortaucipir PET scan Receives: Drug: Flortaucipir F18; Procedure: Brain PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Evaluation of Scan Results
Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's disease (AD) scan pattern = In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the posterolateral temporal (PLT), parietal, or occipital region(s). Moderate AD scan pattern = In either hemisphere, increased neocortical activity limited to the PLT or occipital region(s). Not AD scan pattern = No increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.
Measured: Baseline scan
Quantitative Evaluation of Scan Results
Standard Uptake Value Ratio (SUVr) by amyloid status using a weighted cortical average. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Measured: 75 minutes post dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start23 Mar 2017
- Primary completion14 Aug 2018
- Study completion17 Aug 2018
Why it stopped: study terminated due to lower than expected enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cognitive DeclineStudies 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avid Radiopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study chair, Avid Radiopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052972
- Sponsor's protocol ID
- 18F-AV-1451-A20
- Status last verified
- Sep 2020
- First submitted
- 10 Feb 2017
- Last updated
- 25 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flortaucipir (18F) PET Imaging in the BIOCARD Study
- ClinicalTrials.gov ID
- NCT03052972
- Acronym / sponsor ID
- 18F-AV-1451-A20
- Conditions
- Cognitive Decline
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study terminated due to lower than expected enrollment
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 14 Aug 2018 (actual)
- Study completion
- 17 Aug 2018 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Posted 13 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the imaging characteristics of Flortaucipir (18F-AV-1451) in subjects who participated in the Biomarkers of Cognitive Decline Among Normal Individuals (BIOCARD) study at Johns Hopkins University.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amyloid Positive | Experimental | Drug: Flortaucipir F18, Procedure: Brain PET scanClinically normal amyloid positive subjects from BIOCARD study receiving a flortaucipir PET scan |
| Amyloid Negative | Experimental | Drug: Flortaucipir F18, Procedure: Brain PET scanClinically normal amyloid negative subjects from BIOCARD study receiving a flortaucipir PET scan |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females that have provided consent and are currently enrolled in BIOCARD study
- Ability to tolerate PET scan procedures
- Ability to provide informed consent for study procedures
Key exclusion criteria (8 listed)
- Has condition(s) that could augment risk to participant or compromise ability to tolerate experimental procedures or interfere with analysis of the study data as determined by the investigator
- Has a history of risk factors for Torsades de Pointes or taking medications known to cause QT prolongation.
- Has electrocardiogram acquired prior to initial flortaucipir scan that clinically contradicts subject's participation in the study as determined by the investigator. Bazett's corrected QT (QTcB) interval must be assessed and not exceed accepted values (458 msec in males, 474 msec in females).
- Females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraceptive methods.
- Has hypersensitivity to flortaucipir
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 |
|---|---|---|
| Flortaucipir F18Also: 18F-AV-1451, [F-18]T807, LY3191748, Tauvid370 megabecquerel (MBq)(10 millicurie [mCi]) single dose | Drug | Amyloid Negative, Amyloid Positive |
| Brain PET scanpositron emission tomography (PET) scan of the brain | Procedure or surgery | Amyloid Negative, Amyloid Positive |
Primary outcome
Qualitative Evaluation of Scan Results
Time frame: Baseline scan
Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's disease (AD) scan pattern = In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the posterolateral temporal (PLT), parietal, or occipital region(s). Moderate AD scan pattern = In either hemisphere, increased neocortical activity limited to the PLT or occipital region(s). Not AD scan pattern = No increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.
Quantitative Evaluation of Scan Results
Time frame: 75 minutes post dose administration
Standard Uptake Value Ratio (SUVr) by amyloid status using a weighted cortical average. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BIOCARD Study SummaryLink provided by the sponsor.
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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.
Medical Director study chair
Avid Radiopharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Flortaucipir F18 and Brain PET scan in people with Cognitive Decline, run by Avid Radiopharmaceuticals 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 25 Sep 2020. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Qualitative Evaluation of Scan Results (time frame: Baseline scan). The study lists 2 primary outcomes in all. 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 25 Sep 2020.