Alzheimer's DiseasePhase 4NCT02107599
The Feasibility of Florbetapir Quantitation in Europe
A Phase 4 study testing Florbetapir (18F) in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 1 site in Netherlands.
Trial summary
This study will evaluate whether the addition of quantitation as an adjunct to visual interpretations significantly improves the accuracy of Amyvid scan interpretation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Florbetapir (18F)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2014to May 2014
- Phase
- Phase 4
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Readers have undergone Amyvid reader training
- Readers have not more than minimal experience with quantitation of amyloid PET scans
Who cannot join
- Readers have previously been trained to quantitate amyloid PET scans
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Improvement in Reader Accuracy When Using a Read Method That Incorporates Commercially Available Quantitative Analysis Software as an Adjunct to the Clinical Visual Interpretation of Amyvid Brain Scans
This study will evaluate whether the addition of quantitation as an adjunct to visual interpretations significantly improves the accuracy of Amyvid scan interpretation.
- Conditions
- Alzheimer's Disease
- Being tested
- Florbetapir (18F)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Florbetapir (18F)Drug
Also called Florbetapir F 18, Amyvid, 18F-AV-45
No Florbetapir (18F) will be administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| Physician Readers | Experimental | Physician readers will interpret Amyvid scans using qualitative analysis followed by the use of quantitation. No subjects will be exposed to Florbetapir(18F) as part of this study. Receives: Drug: Florbetapir (18F) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Reader Accuracy After Application of Quantitation Software
Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values >0 indicate an improvement in scan interpretation accuracy and values <0 indicate a decline in scan interpretation accuracy after application of quantitation software.
NRI = [P(up,event)-P(down,event)]-[P(up,nonevent)-P(down,nonevent)] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative
Only the 46 scans with autopsy from A16 are used for this outcome measure.
Measured: Scan acquired 50-60 minutes post injection
Secondary outcomes (1)
Change in Scan Interpretation Reliability After Application of Quantitation Software
Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values >0 indicate an improvement in scan interpretation accuracy and values <0 indicate a decline in scan interpretation accuracy after application of quantitation software.
NRI = [P(up,event)-P(down,event)]-[P(up,nonevent)-P(down,nonevent)] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative
Only the 46 scans with autopsy from A16 are used for this outcome measure.
Measured: Scan acquired 50-60 minutes post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionMay 2014
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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avid Radiopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Avid Radiopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107599
- Sponsor's protocol ID
- 18F-AV-45-QP02
- Status last verified
- Jun 2015
- First submitted
- 4 Apr 2014
- Last updated
- 9 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Improvement in Reader Accuracy When Using a Read Method That Incorporates Commercially Available Quantitative Analysis Software as an Adjunct to the Clinical Visual Interpretation of Amyvid Brain Scans
- ClinicalTrials.gov ID
- NCT02107599
- Acronym / sponsor ID
- 18F-AV-45-QP02
- Conditions
- Alzheimer's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Posted 9 Jul 2015
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 whether the addition of quantitation as an adjunct to visual interpretations significantly improves the accuracy of Amyvid scan interpretation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physician Readers | Experimental | Drug: Florbetapir (18F)Physician readers will interpret Amyvid scans using qualitative analysis followed by the use of quantitation. No subjects will be exposed to Florbetapir(18F) as part of this study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Readers have undergone Amyvid reader training
- Readers have not more than minimal experience with quantitation of amyloid PET scans
Key exclusion criteria (1 listed)
- Readers have previously been trained to quantitate amyloid PET scans
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 |
|---|---|---|
| Florbetapir (18F)Also: Florbetapir F 18, Amyvid, 18F-AV-45No Florbetapir (18F) will be administered in this study. | Drug | Physician Readers |
Primary outcome
Change in Reader Accuracy After Application of Quantitation Software
Time frame: Scan acquired 50-60 minutes post injection
Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values >0 indicate an improvement in scan interpretation accuracy and values <0 indicate a decline in scan interpretation accuracy after application of quantitation software. NRI = [P(up,event)-P(down,event)]-[P(up,nonevent)-P(down,nonevent)] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative Only the 46 scans with autopsy from A16 are used for this outcome measure.
1 secondary outcome
Change in Scan Interpretation Reliability After Application of Quantitation Software
Time frame: Scan acquired 50-60 minutes post injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
- 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 director
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 4 study testing Florbetapir (18F) in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 1 site in Netherlands.
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 1 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 9 Jul 2015. 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 Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 9 Jul 2015). 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 Reader Accuracy After Application of Quantitation Software (time frame: Scan acquired 50-60 minutes post injection). 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 9 Jul 2015.