Alzheimer's DiseasePhase 2NCT02278367
Clinical Evaluation of Flortaucipir F 18
A Phase 2 study testing Flortaucipir F18 and Brain PET scan in people with Alzheimer's Disease and Traumatic Brain Injury, run by Avid Radiopharmaceuticals at 5 sites in United States.
Trial summary
This study is designed to expand the database of flortaucipir F 18 safety and tau binding as measured by PET imaging and to provide standardized conditions for flortaucipir PET use, data collection and analysis to facilitate companion studies including, but not limited to, longitudinal studies of aging, depression… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Traumatic Brain Injury, Depression
- What is being tested?
- Flortaucipir F18 and Brain PET scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2014to 26 Jun 2019
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who have a historical volumetric magnetic resonance imaging (MRI) as part of the companion study
Who cannot join
- Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances
- Have a screening electrocardiogram with a corrected QT interval (QTc) > 450 msec if male or QTc > 470 msec if female
- Have a history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs known to cause QT-prolongation. Patients with a prolonged QTc interval in the setting of intraventricular conduction block may be enrolled with sponsor approval
- Have a history of drug or alcohol dependence within the last year, or prior prolonged history of dependence unless approved by the sponsor
- Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
- Have a history of relevant severe drug allergy or hypersensitivity
Show all 9Show fewer
- Are patients who have received an investigational medication within 30 days prior to the planned imaging session for this study
- Are patients with current clinically significant unstable medical comorbidities
- Are patients who have received a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Center for Vital Longevity at the University of Texas at Dallas
Dallas, Texas, 75235
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106
Yale University
New Haven, Connecticut, 06510
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
About this study
Official title: Clinical Evaluation of 18F-AV-1451
This study is designed to expand the database of flortaucipir F 18 safety and tau binding as measured by PET imaging and to provide standardized conditions for flortaucipir PET use, data collection and analysis to facilitate companion studies including, but not limited to, longitudinal studies of aging, depression, and traumatic brain injury.
- Conditions
- Alzheimer's Disease, Traumatic Brain Injury, Depression
- Being tested
- Flortaucipir F18, Brain PET scan
- Medical subject headings
- Alzheimer Disease, Brain Injuries, Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flortaucipir F18Drug
Also called [F-18]T807, 18F-AV-1451, LY3191748, Tauvid
IV injection, 370 MBq (10 mCi), up to two doses
Brain PET scanProcedure or surgery
positron emission tomography (PET) scan of the brain
| Study group | Role | What they receive |
|---|---|---|
| Flortaucipir PET Scans | Experimental | Not described 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.
Number of Participants With Adverse Events Related to Flortaucipir Administration
Frequency of treatment-emergent adverse events considered related to flortaucipir administration by the study investigator. Related events with a frequency > 1.5% are reported.
(note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in "Adverse Events" section below).
Measured: within 48 hours of drug administration
Flortaucipir PET Scan SUVr
Standard Uptake Value Ratio (SUVr) 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: baseline and follow-up scans
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startDec 2014
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
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 Alzheimer's 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
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avid Radiopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278367
- Sponsor's protocol ID
- 18F-AV-1451-A14
- Status last verified
- Aug 2020
- First submitted
- 28 Oct 2014
- Last updated
- 10 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of 18F-AV-1451
- ClinicalTrials.gov ID
- NCT02278367
- Acronym / sponsor ID
- 18F-AV-1451-A14
- Conditions
- Alzheimer's Disease, Traumatic Brain Injury, Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2014 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 30 Oct 2014 (estimated)
- Results
- Posted 10 Sep 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 expand the database of flortaucipir F 18 safety and tau binding as measured by PET imaging and to provide standardized conditions for flortaucipir PET use, data collection and analysis to facilitate companion studies including, but not limited to, longitudinal studies of aging, depression, and traumatic brain injury.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flortaucipir PET Scans | Experimental | Drug: Flortaucipir F18, Procedure: Brain PET scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who have a historical volumetric magnetic resonance imaging (MRI) as part of the companion study
Key exclusion criteria (9 listed)
- Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances
- Have a screening electrocardiogram with a corrected QT interval (QTc) > 450 msec if male or QTc > 470 msec if female
- Have a history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs known to cause QT-prolongation. Patients with a prolonged QTc interval in the setting of intraventricular conduction block may be enrolled with sponsor approval
- Have a history of drug or alcohol dependence within the last year, or prior prolonged history of dependence unless approved by the sponsor
- Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
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: [F-18]T807, 18F-AV-1451, LY3191748, TauvidIV injection, 370 MBq (10 mCi), up to two doses | Drug | Flortaucipir PET Scans |
| Brain PET scanpositron emission tomography (PET) scan of the brain | Procedure or surgery | Flortaucipir PET Scans |
Primary outcome
Number of Participants With Adverse Events Related to Flortaucipir Administration
Time frame: within 48 hours of drug administration
Frequency of treatment-emergent adverse events considered related to flortaucipir administration by the study investigator. Related events with a frequency > 1.5% are reported. (note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in "Adverse Events" section below).
Flortaucipir PET Scan SUVr
Time frame: baseline and follow-up scans
Standard Uptake Value Ratio (SUVr) 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 10 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flortaucipir F18 and Brain PET scan in people with Alzheimer's Disease and Traumatic Brain Injury, run by Avid Radiopharmaceuticals at 5 sites 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 1 inclusion and 9 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 10 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 5 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 10 Sep 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?
Number of Participants With Adverse Events Related to Flortaucipir Administration (time frame: within 48 hours of drug administration). 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 10 Sep 2020.