Alzheimer's DiseasePhase 3NCT01447719

Autopsy Follow-up of Subjects Previously Imaged With Florbetapir F 18 (18F-AV-45) PET in Trial 18F-AV-45-A07

A Phase 3 study testing florbetapir F 18 in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to test the relationship between measurements of brain amyloid using florbetapir F 18 PET imaging and true levels of amyloid plaque density as measured by histopathological assessment. The study will address the following specific aims: 1. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Alzheimer's Disease
What is being tested?: florbetapir F 18
How many people: 110 participants
Where: 22 sitesUnited States
Study dates: Mar 2010to Jul 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects are enrolled in this study if they:
Met entrance criteria and were enrolled and imaged in trial 18F-AV-45-A07 (NCT00857415)
Gave informed consent for the 18F-AV-45-A07 (NCT00857415) study procedures and brain donation consistent with the legal requirements of the State in which they are enrolled and the State in which they die
Consent to participate in the 18F-AV-45-A16 (NCT01447719) extension protocol, if required by the IRB
Reconfirm their consent to a research brain autopsy, if required by the IRB.

Who cannot join

None listed.

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

United States22 sites

Research Site
Albany, New York, 12208
Research Site
Baltimore, Maryland, 21221
Research Site
Centerville, Ohio, 45459
Research Site
Charleston, South Carolina, 29425
Research Site
Durham, North Carolina, 27710
Research Site
Fort Myers, Florida, 33912
Research Site
Hattiesburg, Mississippi, 39401
Research Site
Irvine, California, 92697
Research Site
Johnson City, Tennessee, 37614
Research Site
Little Rock, Arkansas, 72211
Research Site
Miami, Florida, 33137
Research Site
Miami Beach, Florida, 33140
Research Site
Miami Springs, Florida, 33166
Research Site
New Hyde Park, New York, 11040
Research Site
Oklahoma City, Oklahoma, 73112
Research Site
Orlando, Florida, 32835
Research Site
Phoenix, Arizona, 85006
Research Site
Sarasota, Florida, 34231
Research Site
St Louis, Missouri, 63141
Research Site
St. Petersburg, Florida, 33709
Research Site
Sun City, Arizona, 85351
Research Site
West Palm Beach, Florida, 33407

Other trials in United States

About this study

To expand the number of subjects included in the A07 (NCT00857415) trial correlation analysis (measuring the correlation between the global visual rating of brain amyloid plaque density on an independent blinded read of the florbetapir F 18 PET scan and the cortical amyloid plaque density at autopsy as assessed by histopathology for subjects in the autopsy cohort).
To determine the sensitivity and specificity of an independent blinded visual read assessment of the florbetapir F 18 PET scan (Aβ+ or Aβ-) versus the final blinded neuropathological assessment made at autopsy.

Conditions: Alzheimer's Disease
Being tested: florbetapir F 18
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
No study drug administered in this trial. Study subjects previously dosed with 18F-AV-45 in study 18F-AV-45-A07 (NCT00857415) are followed to autopsy in this extension study.

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensitivity Analysis in All Autopsy Population
Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD (Consortium to Establish a Registry for AD) criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).
Measured: at autopsy within 24 months of florbetapir PET scan
Specificity Analysis in All Autopsy Population
Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).
Measured: at autopsy within 24 months of florbetapir PET scan
Correlation of Florbetapir-PET Image and Amyloid Plaque Density
Spearman's rank order correlation of the median visual read of the florbetapir-PET image and the amyloid plaque density assessed post-mortem by quantitative immunohistochemistry (IHC) averaged across 6 brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Measured: at autopsy within 24 months of florbetapir PET scan

Secondary outcomes (2)

Sensitivity Analysis in Subjects With Autopsy Within 1 Year of Scan
Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).
Measured: at autopsy within 12 months of florbetapir PET scan
Specificity Analysis in Subjects With Autopsy Within 1 Year of Scan
Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).
Measured: at autopsy within 12 months of florbetapir PET scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Jul 2011

First posted6 Oct 2011 (estimated)
Study startMar 2010
Primary completionMar 2011
Study completionJul 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.
Publications (1)Papers the sponsor has linked to this study.
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: None (open label)
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01447719
Sponsor's protocol ID: 18F-AV-45-A16
Status last verified: Mar 2025
First submitted: 20 May 2011
Last updated: 21 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Clark CM, Pontecorvo MJ, Beach TG, Bedell BJ, Coleman RE, Doraiswamy PM, Fleisher AS, Reiman EM, Sabbagh MN, Sadowsky CH, Schneider JA, Arora A, Carpenter AP, Flitter ML, Joshi AD, Krautkramer MJ, Lu M, Mintun MA, Skovronsky DM; AV-45-A16 Study Group. Cerebral PET with florbetapir compared with neuropathology at autopsy for detection of neuritic amyloid-beta plaques: a prospective cohort study. Lancet Neurol. 2012 Aug;11(8):669-78. doi: 10.1016/S1474-4422(12)70142-4. Epub 2012 Jun 28.
PubMed 22749065

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Autopsy Follow-up of Subjects Previously Imaged With Florbetapir F 18 (18F-AV-45) PET in Trial 18F-AV-45-A07
ClinicalTrials.gov ID: NCT01447719
Acronym / sponsor ID: 18F-AV-45-A16
Conditions: Alzheimer's Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Mar 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 6 Oct 2011 (estimated)
Results: Posted 7 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To expand the number of subjects included in the A07 (NCT00857415) trial correlation analysis (measuring the correlation between the global visual rating of brain amyloid plaque density on an independent blinded read of the florbetapir F 18 PET scan and the cortical amyloid plaque density at autopsy as assessed by histopathology for subjects in the autopsy cohort).
To determine the sensitivity and specificity of an independent blinded visual read assessment of the florbetapir F 18 PET scan (Aβ+ or Aβ-) versus the final blinded neuropathological assessment made at autopsy.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Met entrance criteria and were enrolled and imaged in trial 18F-AV-45-A07 (NCT00857415)
Gave informed consent for the 18F-AV-45-A07 (NCT00857415) study procedures and brain donation consistent with the legal requirements of the State in which they are enrolled and the State in which they die
Consent to participate in the 18F-AV-45-A16 (NCT01447719) extension protocol, if required by the IRB
Reconfirm their consent to a research brain autopsy, if required by the IRB.

Key exclusion criteria (0 listed)

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, florbetapirNo study drug administered in this trial. Study subjects previously dosed with 18F-AV-45 in study 18F-AV-45-A07 (NCT00857415) are followed to autopsy in this extension study.	Drug	–

Primary outcome

Sensitivity Analysis in All Autopsy Population
Time frame: at autopsy within 24 months of florbetapir PET scan
Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD (Consortium to Establish a Registry for AD) criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).
Specificity Analysis in All Autopsy Population
Time frame: at autopsy within 24 months of florbetapir PET scan
Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).
Correlation of Florbetapir-PET Image and Amyloid Plaque Density
Time frame: at autopsy within 24 months of florbetapir PET scan
Spearman's rank order correlation of the median visual read of the florbetapir-PET image and the amyloid plaque density assessed post-mortem by quantitative immunohistochemistry (IHC) averaged across 6 brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.

2 secondary outcomes

Sensitivity Analysis in Subjects With Autopsy Within 1 Year of Scan
Time frame: at autopsy within 12 months of florbetapir PET scan
Specificity Analysis in Subjects With Autopsy Within 1 Year of Scan
Time frame: at autopsy within 12 months of florbetapir PET scan

Results and safety

Results posted to the registry on 7 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Autopsy Cohort	152	59

Primary outcome: Sensitivity Analysis in All Autopsy Population

Time frame: at autopsy within 24 months of florbetapir PET scan. Number. Unit: participants

Measure	Subjects With Moderate or Frequent Plaques at Autopsy n = 39
Florbetapir PET positive (majority interpretation)	36
Florbetapir PET negative (majority interpretation)	3

Subjects With Moderate or Frequent Plaques at Autopsy: Sensitivity: 92 (95% CI 78 to 98)

Population analysed: 39 of 59 subjects from all autopsy population had moderate to frequent neuritic plaques at autopsy

Primary outcome: Specificity Analysis in All Autopsy Population

Time frame: at autopsy within 24 months of florbetapir PET scan. Number. Unit: participants

Measure	Subjects With no or Sparse Plaques at Autopsy n = 20
Florbetapir PET positive (majority interpretation)	0
Florbetapir PET negative (majority interpretation)	20

Subjects With no or Sparse Plaques at Autopsy: Specificity: 100 (95% CI 80 to 100)

Population analysed: 20 of 59 subjects from the all autopsy population had no or sparse neuritic plaques at autopsy

Primary outcome: Correlation of Florbetapir-PET Image and Amyloid Plaque Density

Time frame: at autopsy within 24 months of florbetapir PET scan. Number (95% Confidence Interval). Unit: Correlation coefficient

Measure	All Autopsy Population n = 59
Value	0.76 (0.62 to 0.85)

All Autopsy Population: Correlation coefficient: 0.76 (95% CI 0.62 to 0.85), p <0.0001, Spearman's Rank Order Correlation test

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: No adverse events were collected in this study, as this study only followed study A07(NCT01447719) subjects to autopsy. Adverse events are reported with study A07 (NCT00857415).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Autopsy Cohort	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22749065Clark CM, Pontecorvo MJ, Beach TG, Bedell BJ, Coleman RE, Doraiswamy PM, Fleisher AS, Reiman EM, Sabbagh MN, Sadowsky CH, Schneider JA, Arora A, Carpenter AP, Flitter ML, Joshi AD, Krautkramer MJ, Lu M, Mintun MA, Skovronsky DM; AV-45-A16 Study Group. Cerebral PET with florbetapir compared with neuropathology at autopsy for detection of neuritic amyloid-beta plaques: a prospective cohort study. Lancet Neurol. 2012 Aug;11(8):669-78. doi: 10.1016/S1474-4422(12)70142-4. Epub 2012 Jun 28.

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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.

The record lists no contact. Use the official record to reach the sponsor.

22 sites in 1 country: see every site and its status.

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 at 22 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 5 inclusion and 0 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 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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 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 7 May 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?

Sensitivity Analysis in All Autopsy Population (time frame: at autopsy within 24 months of florbetapir PET scan). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01447719, which also lists 1 linked publication.

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 21 Mar 2025.