Alzheimer's DiseasePhase 2NCT02051764
Imaging Characteristics of a Follow-up 18F-AV-1451 Scan
A Phase 2 study testing Flortaucipir F18, Florbetapir F 18 and Brain PET Scan in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 4 sites in United States.
Trial summary
This study will evaluate the imaging characteristics of flortaucipir in subjects with a previous flortaucipir scan in order to assess the rate of change of tau deposition over time. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Flortaucipir F18, Florbetapir F 18 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
- 44 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2014to Dec 2016
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a previous 18F-AV-1451 brain scan
- Can tolerate up to two Positron Emission Tomography (PET) imaging sessions and a Magnetic Resonance Imaging (MRI) scan
- Ability to provide informed consent
Who cannot join
- Current clinically significant psychiatric disease
- Are claustrophobic
- Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
- Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
- Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
- Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Hoag Memorial Hospital
Newport Beach, California, 92663
UC Irvine Medical Center
Orange, California, 92868
Center for Clinical Imaging Research, Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: An Open Label, Multicenter Study, Evaluating the Imaging Characteristics of a Follow-up 18F-AV-1451 Scan in Subjects Who Have Had a Prior 18F-AV-1451 Scan
This study will evaluate the imaging characteristics of flortaucipir in subjects with a previous flortaucipir scan in order to assess the rate of change of tau deposition over time.
- Conditions
- Alzheimer's Disease
- Being tested
- Flortaucipir F18, Florbetapir F 18, Brain PET Scan
- Medical subject headings
- Alzheimer Disease
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, LY3191748, [F-18]T807
370 megabecquerel (MBq) IV single-dose
Florbetapir F 18Drug
Also called Amyvid, 18F-AV-45
370 megabecquerel (MBq) IV single-dose
Brain PET ScanProcedure or surgery
positron emission tomography (PET) scan of the brain
| Study group | Role | What they receive |
|---|---|---|
| Follow-up Flortaucipir PET Scan | Experimental | Not described Receives: Drug: Flortaucipir F18; Drug: Florbetapir F 18; Procedure: Brain PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tau Deposition
Rate of tau deposition change as measured by flortaucipir standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Measured: baseline scan and at least 6 months after baseline scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: 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 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avid Radiopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study chair, Avid Radiopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051764
- Sponsor's protocol ID
- 18F-AV-1451-A04
- Status last verified
- Sep 2020
- First submitted
- 30 Jan 2014
- Last updated
- 7 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter Study, Evaluating the Imaging Characteristics of a Follow-up 18F-AV-1451 Scan in Subjects Who Have Had a Prior 18F-AV-1451 Scan
- ClinicalTrials.gov ID
- NCT02051764
- Acronym / sponsor ID
- 18F-AV-1451-A04
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lower than expected enrollment
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 31 Jan 2014 (estimated)
- Results
- Posted 7 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 will evaluate the imaging characteristics of flortaucipir in subjects with a previous flortaucipir scan in order to assess the rate of change of tau deposition over time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow-up Flortaucipir PET Scan | Experimental | Drug: Flortaucipir F18, Drug: Florbetapir F 18, Procedure: Brain PET Scan |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a previous 18F-AV-1451 brain scan
- Can tolerate up to two Positron Emission Tomography (PET) imaging sessions and a Magnetic Resonance Imaging (MRI) scan
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- Current clinically significant psychiatric disease
- Are claustrophobic
- Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
- Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
- 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: 18F-AV-1451, LY3191748, [F-18]T807370 megabecquerel (MBq) IV single-dose | Drug | Follow-up Flortaucipir PET Scan |
| Florbetapir F 18Also: Amyvid, 18F-AV-45370 megabecquerel (MBq) IV single-dose | Drug | Follow-up Flortaucipir PET Scan |
| Brain PET Scanpositron emission tomography (PET) scan of the brain | Procedure or surgery | Follow-up Flortaucipir PET Scan |
Primary outcome
Change in Tau Deposition
Time frame: baseline scan and at least 6 months after baseline scan
Rate of tau deposition change as measured by flortaucipir standardized uptake value ratio (SUVr). For SUVr, a value of 1 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 7 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Chief Medical Officer study chair
Avid Radiopharmaceuticals
4 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, Florbetapir F 18 and Brain PET Scan in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 4 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 3 inclusion and 6 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 7 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 4 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 7 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?
Change in Tau Deposition (time frame: baseline scan and at least 6 months after baseline scan). 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 7 Sep 2020.