Alzheimers DiseasePhase 4NCT01946243
The Feasibility of Florbetapir Quantitation
A Phase 4 study testing Florbetapir F18 in people with Alzheimers Disease, run by Avid Radiopharmaceuticals at 1 site in United States.
Trial summary
The overall objective of the study is to assess the feasibility of implementing a quantitative process of florbetapir F 18 scan interpretation. The hypothesis is that the use of quantitative analysis will increase the accuracy of florbetapir F 18 scan interpretation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimers Disease
- What is being tested?
- Florbetapir F18
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Apr 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 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: The Feasibility and Reliability of Utilizing Commercially Available Quantitative Analysis Software as an Adjunct to the Clinical Qualitative Interpretation of Amyvid Brain Scans
The overall objective of the study is to assess the feasibility of implementing a quantitative process of florbetapir F 18 scan interpretation. The hypothesis is that the use of quantitative analysis will increase the accuracy of florbetapir F 18 scan interpretation.
- Conditions
- Alzheimers Disease
- Being tested
- Florbetapir F18
- 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 F18Drug
Also called Amyvid, 18F-AV-45, florbetapir
No Florbetapir F 18 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 F 18 as part of this study. Receives: Drug: Florbetapir F18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Accuracy (MIMNeuro Software, Low Accuracy Readers)
Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.
Measured: Scan acquired 50-60 min post-injection
Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm Low Accuracy Readers)
Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.
Measured: Scan acquired 50-60 min post-injection
Secondary outcomes (4)
Change in Total Accuracy (MIMNeuro Software, All Readers)
Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.
Measured: Scan acquired 50-60 min post-injection
Change in Reliability (MIMNeuro Software)
Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretation alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics.
Measured: Scan acquired 50-60 min post-injection
Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm All Readers)
Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.
Measured: Scan acquired 50-60 min post-injection
Change in Reliability (Siemens Syngo.PET Software)
Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretations alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics.
Measured: Scan acquired 50-60 min post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2014
- Study completionApr 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 Alzheimers 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
- NCT01946243
- Sponsor's protocol ID
- 18F-AV-45-QP01
- Status last verified
- Jun 2015
- First submitted
- 17 Sep 2013
- Last updated
- 29 Jun 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 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Reliability of Utilizing Commercially Available Quantitative Analysis Software as an Adjunct to the Clinical Qualitative Interpretation of Amyvid Brain Scans
- ClinicalTrials.gov ID
- NCT01946243
- Acronym / sponsor ID
- 18F-AV-45-QP01
- Conditions
- Alzheimers Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 Sep 2013 (estimated)
- Results
- Posted 1 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of the study is to assess the feasibility of implementing a quantitative process of florbetapir F 18 scan interpretation. The hypothesis is that the use of quantitative analysis will increase the accuracy of florbetapir F 18 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 F18Physician readers will interpret Amyvid scans using qualitative analysis followed by the use of quantitation. No subjects will be exposed to Florbetapir F 18 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 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 F18Also: Amyvid, 18F-AV-45, florbetapirNo Florbetapir F 18 will be administered in this study. | Drug | Physician Readers |
Primary outcome
Change in Total Accuracy (MIMNeuro Software, Low Accuracy Readers)
Time frame: Scan acquired 50-60 min post-injection
Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.
Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm Low Accuracy Readers)
Time frame: Scan acquired 50-60 min post-injection
Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.
4 secondary outcomes
Change in Total Accuracy (MIMNeuro Software, All Readers)
Time frame: Scan acquired 50-60 min post-injection
Change in Reliability (MIMNeuro Software)
Time frame: Scan acquired 50-60 min post-injection
Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm All Readers)
Time frame: Scan acquired 50-60 min post-injection
Change in Reliability (Siemens Syngo.PET Software)
Time frame: Scan acquired 50-60 min post-injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 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 F18 in people with Alzheimers Disease, 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 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 29 Jun 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 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 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 1 Jun 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 Total Accuracy (MIMNeuro Software, Low Accuracy Readers) (time frame: Scan acquired 50-60 min post-injection). 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 29 Jun 2015.