Alzheimer's DiseasePhase 3NCT01565382
Evaluation of Inter-reader Reliability Using Images From Subjects With Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI)
A Phase 3 study testing florbetapir F 18 in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals.
Trial summary
Re-read of brain amyloid scans acquired in previous AV-45 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- florbetapir F 18
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Feb 2011
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female >=50 years of age
- Meet National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) criteria for probable AD with Mini-Mental State Examination (MMSE) score of 10-24
- Male or female >=50 years of age
- Have a Clinical Dementia Rating (CDR) of 0.5
- MMSE >24
Who cannot join
- Have a history or current diagnosis of other neurologic disease
- Have had or currently have a diagnosis of other neurodegenerative disease
- Have participated in experimental therapy targeted to amyloid plaque
- Readers:
- •Private nuclear medicine physicians with no prior training in reading florbetapir-PET scans
About this study
Official title: Evaluation of Physician Training for Interpretation of Florbetapir-PET Scans: Evaluation of Inter-reader Reliability Using Images From Subjects With a Clinical Presentation of AD or MCI
Re-read of brain amyloid scans acquired in previous AV-45 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI).
- Conditions
- Alzheimer's Disease
- Being tested
- florbetapir F 18
- Keywords
- Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging
- 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 F 18Drug
Also called 18F-AV-45, Amyvid, florbetapir
IV injection, 370MBq (10mCi), single dose (intervention for Study A05 participants, source of scans for this study)
| Study group | Role | What they receive |
|---|---|---|
| Independent, blinded reader trainees | Experimental | Seven practicing nuclear medicine physicians with no prior training in reading scans from florbetapir-PET, or other amyloid imaging agents. Receives: Drug: florbetapir F 18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-reader Agreement - Median Kappa Statistic
Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Simple kappa statistics were calculated for each reader versus the other 6 readers. Primary outcome measure was the median kappa of each reader versus the other 6 readers.
Measured: 50-60 min after injection
Secondary outcomes (1)
Overall Inter-reader Agreement - Fleiss' Kappa
Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Fleiss' kappa was calculated across all inter-reader comparisons.
Measured: 50-60 min after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startFeb 2011
- Primary completionFeb 2011
- Study completionFeb 2011
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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 40 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
- NCT01565382
- Sponsor's protocol ID
- 18F-AV-45-A09
- Status last verified
- Jul 2022
- First submitted
- 26 Mar 2012
- Last updated
- 16 Aug 2022
- 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 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physician Training for Interpretation of Florbetapir-PET Scans: Evaluation of Inter-reader Reliability Using Images From Subjects With a Clinical Presentation of AD or MCI
- ClinicalTrials.gov ID
- NCT01565382
- Acronym / sponsor ID
- 18F-AV-45-A09
- Conditions
- Alzheimer's Disease
- Keywords
- Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 28 Mar 2012 (estimated)
- Results
- Posted 27 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Re-read of brain amyloid scans acquired in previous AV-45 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Independent, blinded reader trainees | Experimental | Drug: florbetapir F 18Seven practicing nuclear medicine physicians with no prior training in reading scans from florbetapir-PET, or other amyloid imaging agents. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (5 listed)
- •Private nuclear medicine physicians with no prior training in reading florbetapir-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 F 18Also: 18F-AV-45, Amyvid, florbetapirIV injection, 370MBq (10mCi), single dose (intervention for Study A05 participants, source of scans for this study) | Drug | Independent, blinded reader trainees |
Primary outcome
Inter-reader Agreement - Median Kappa Statistic
Time frame: 50-60 min after injection
Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Simple kappa statistics were calculated for each reader versus the other 6 readers. Primary outcome measure was the median kappa of each reader versus the other 6 readers.
1 secondary outcome
Overall Inter-reader Agreement - Fleiss' Kappa
Time frame: 50-60 min after injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing florbetapir F 18 in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals.
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 5 inclusion and 5 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 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 27 Jun 2012). 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?
Inter-reader Agreement - Median Kappa Statistic (time frame: 50-60 min after 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 16 Aug 2022.