Alzheimer's DiseasePhase 3NCT02516046

18F-AV-1451 Autopsy Study

A Phase 3 study testing Flortaucipir F18 and PET Scan in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 31 sites in 2 countries.

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 ante-mortem flortaucipir Positron Emission Tomography (PET) imaging and tau neurofibrillary pathology associated with Alzheimer's disease (AD), as measured at autopsy. 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?: Flortaucipir F18 and 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: 156 participants
Where: 31 sitesin 2 countries
Study dates: Sep 2015to 15 Jul 2018
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

Have a projected life expectancy of ≤ 6 months
Can tolerate a 20 minute PET scan
Give informed consent or have a legally authorized representative to consent for study procedures and brain donation consistent with the legal requirements of the State in which they die

Who cannot join

Aggressively being treated with life sustaining measures
Known to have a structural brain lesion that would interfere either with PET imaging or pathological assessment
Clinically significant infectious disease
Currently receiving any investigational medications except with permission from the study sponsor
Participated in an experimental study with an amyloid or tau targeting agent
Suspected encephalopathy due to alcoholism or end-stage liver disease
Females of childbearing potential
History of risk factors for Torsades de Pointes or are currently taking medication known to cause QT prolongation

Trial locations and contacts

31 sites in 2 countries.

Country

City, postcode or hospital

31 sites in 2 countries

United States30 sites

Emory University Brain Health Center
Atlanta, Georgia, 30329
Overlake Internal Medicine Associates, PS
Bellevue, Washington, 98004
Valley Medical Primary Care
Centerville, Ohio, 45459
Hospice of the Western Reserve
Cleveland, Ohio, 44119
Duke University Medical Center
Durham, North Carolina, 27710
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912
Adirondack Medical Research Center
Glens Falls, New York, 12801
Steinberg Diagnostics
Henderson, Nevada, 89052
Galiz Research
Hialeah, Florida, 33016
Houston Methodist Research Institute
Houston, Texas, 77030
Sante Clinical Research
Kerrville, Texas, 78028
Cherlin Research
Los Gatos, California, 95032
Merritt Island Medical Research
Merritt Island, Florida, 32952
Miami Jewish Health Systems
Miami, Florida, 33137
D de la Vega MD Research Group
Miami, Florida, 33185
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658
American Clinical Trials, LLC (Site 1216)
Oklahoma City, Oklahoma, 73112
Oklahoma Behavioral Health
Oklahoma City, Oklahoma, 73112
Bioclinica
Orlando, Florida, 32806
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Rhode Island Hospital
Providence, Rhode Island, 02903
Alzheimer's Disease Center
Quincy, Massachusetts, 02169
California Research Foundation
San Diego, California, 92103
Pacific Research Network
San Diego, California, 92103
Ray Dolby Brain Health Center
San Francisco, California, 94114
Syrentis Clinical Research
Santa Ana, California, 92705
University of Washington Medicine
Seattle, Washington, 98104
Clarity Clinical Research, LLC
Syracuse, New York, 13210
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157

Other trials in United States

Australia1 site

University of Melbourne
Parkville, Victoria, 3010

Other trials in Australia

About this study

Official title: A Clinico-Pathological Study of the Correspondence Between 18F-AV-1451 PET Imaging and Post-Mortem Assessment of Tau Pathology

Conditions: Alzheimer's Disease
Being tested: Flortaucipir F18, 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 [F-18]T807, 18F-AV-1451, LY3191748
370 megabecquerel (MBq) IV single-dose
PET ScanProcedure or surgery
positron emission tomography (PET) scan

Study groups in NCT02516046
Study group	Role	What they receive
Flortaucipir PET Scan	Experimental	Not described Receives: Drug: Flortaucipir F18; Procedure: PET Scan

What is being measured

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

Primary Outcome 1: Diagnostic Performance of Individual Readers (NFT Score)
Sensitivity and specificity of 5 independent readers' interpretations of ante-mortem flortaucipir PET imaging for detection of a pattern of flortaucipir neocortical uptake that corresponds to neurofibrillary tangles (NFT) Score of B3 (Hyman et al., 2012; Montine et al., 2012). NFT B scores range from B0 (Braak Stage 0; no NFTs in the brain) to B3 (Braak Stage V/VI; widespread NFTs in the brain). Sensitivity and specificity are percentages that can range from 0 to 100%. The hypothesis tested was that, of the 5 independent imaging physicians, at least 3 will have the lower bounds of 2-sided 95% CIs ≥50%, for both sensitivity and specificity.
Measured: at autopsy within 9 months of baseline scan
Primary Outcome 2: Diagnostic Performance of Individual Readers (NIA-AA Autopsy Diagnosis)
Sensitivity and specificity of 5 independent readers' interpretations of ante-mortem flortaucipir imaging for detection of a pattern of flortaucipir neocortical uptake that corresponds to high levels of Alzheimer's disease neuropathologic change (High ADNC) as defined by National Institute on Aging-Alzheimer's Association (NIA-AA) criteria. ADNC categories are None, Low, Intermediate and High, with High indicating the most severe level of AD-related pathology changes in the brain (Hyman et al., Alzheimers Dement. 2012 Jan;8(1):1-13). The hypothesis tested was that, of the 5 independent imaging physicians, at least 3 will have the lower bounds of 2-sided 95% CIs ≥50%, for both sensitivity and specificity.
Measured: at autopsy within 9 months of baseline scan

Secondary outcomes (3)

Flortaucipir Diagnostic Performance (NFT Score)
Sensitivity and specificity of majority interpretation of AD pattern tau PET scan corresponding to NFT Score of B3. The 95% confidence intervals (CI) provided for specificity and sensitivity were based on the Wilson score method. The hypothesis tested was that majority read results had the lower bound of the 2-sided 95% CI greater than or equal to 55% for both sensitivity and specificity.
Measured: at autopsy within 9 months of baseline scan
Flortaucipir Diagnostic Performance (NIA-AA Autopsy Diagnosis)
Sensitivity and specificity of majority interpretation of of AD pattern tau PET scan corresponding to NIA-AA autopsy diagnosis. The 95% CIs provided for specificity and sensitivity were based on the Wilson score method. The hypothesis tested was that majority read results had the lower bound of the 2-sided 95% CI greater than or equal to 55% for both sensitivity and specificity.
Measured: at autopsy within 9 months of baseline scan
Inter-Reader Agreement
Fleiss' Kappa statistics were used to assess inter-reader agreement for the diagnostic decisions associated with primary outcome 1. Fleiss' kappa is a statistical measure for assessing the reliability of agreement between a fixed number of raters when assigning categorical ratings to a number of items or classifying items. Fleiss' kappa can range from 0 to 1 with 1 indicating perfect agreement between the readers. Results are reported as overall agreement, calculated as proportion of scans where reader pairs agreed, divided by the total number of scans read by each reader pair.
Measured: baseline scan

Timeline

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

Sep 201515 Jul 2018

First posted5 Aug 2015 (estimated)
Study startSep 2015
Primary completion13 Jun 2018
Study completion15 Jul 2018

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 (4)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: 156 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02516046
Sponsor's protocol ID: 18F-AV-1451-A16
Status last verified: Sep 2020
First submitted: 3 Aug 2015
Last updated: 7 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Hyman BT, Phelps CH, Beach TG, Bigio EH, Cairns NJ, Carrillo MC, Dickson DW, Duyckaerts C, Frosch MP, Masliah E, Mirra SS, Nelson PT, Schneider JA, Thal DR, Thies B, Trojanowski JQ, Vinters HV, Montine TJ. National Institute on Aging-Alzheimer's Association guidelines for the neuropathologic assessment of Alzheimer's disease. Alzheimers Dement. 2012 Jan;8(1):1-13. doi: 10.1016/j.jalz.2011.10.007.
PubMed 22265587
Montine TJ, Phelps CH, Beach TG, Bigio EH, Cairns NJ, Dickson DW, Duyckaerts C, Frosch MP, Masliah E, Mirra SS, Nelson PT, Schneider JA, Thal DR, Trojanowski JQ, Vinters HV, Hyman BT; National Institute on Aging; Alzheimer's Association. National Institute on Aging-Alzheimer's Association guidelines for the neuropathologic assessment of Alzheimer's disease: a practical approach. Acta Neuropathol. 2012 Jan;123(1):1-11. doi: 10.1007/s00401-011-0910-3. Epub 2011 Nov 20.
PubMed 22101365
Fleisher AS, Pontecorvo MJ, Devous MD Sr, Lu M, Arora AK, Truocchio SP, Aldea P, Flitter M, Locascio T, Devine M, Siderowf A, Beach TG, Montine TJ, Serrano GE, Curtis C, Perrin A, Salloway S, Daniel M, Wellman C, Joshi AD, Irwin DJ, Lowe VJ, Seeley WW, Ikonomovic MD, Masdeu JC, Kennedy I, Harris T, Navitsky M, Southekal S, Mintun MA; A16 Study Investigators. Positron Emission Tomography Imaging With [18F]flortaucipir and Postmortem Assessment of Alzheimer Disease Neuropathologic Changes. JAMA Neurol. 2020 Jul 1;77(7):829-839. doi: 10.1001/jamaneurol.2020.0528.
PubMed 32338734
Pontecorvo MJ, Keene CD, Beach TG, Montine TJ, Arora AK, Devous MD Sr, Navitsky M, Kennedy I, Joshi AD, Lu M, Serrano GE, Sue LI, Intorcia AJ, Rose SE, Wilson A, Hellstern L, Coleman N, Flitter M, Aldea P, Fleisher AS, Mintun MA, Siderowf A. Comparison of regional flortaucipir PET with quantitative tau immunohistochemistry in three subjects with Alzheimer's disease pathology: a clinicopathological study. EJNMMI Res. 2020 Jun 15;10(1):65. doi: 10.1186/s13550-020-00653-x.
PubMed 32542468

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 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinico-Pathological Study of the Correspondence Between 18F-AV-1451 PET Imaging and Post-Mortem Assessment of Tau Pathology
ClinicalTrials.gov ID: NCT02516046
Acronym / sponsor ID: 18F-AV-1451-A16
Conditions: Alzheimer's Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 156 participants (actual)
Lead sponsor: Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: 13 Jun 2018 (actual)
Study completion: 15 Jul 2018 (actual)
First posted: 5 Aug 2015 (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.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Flortaucipir PET Scan	Experimental	Drug: Flortaucipir F18, Procedure: PET Scan

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Have a projected life expectancy of ≤ 6 months
Can tolerate a 20 minute PET scan
Give informed consent or have a legally authorized representative to consent for study procedures and brain donation consistent with the legal requirements of the State in which they die

Key exclusion criteria (8 listed)

Aggressively being treated with life sustaining measures
Known to have a structural brain lesion that would interfere either with PET imaging or pathological assessment
Clinically significant infectious disease
Currently receiving any investigational medications except with permission from the study sponsor
Participated in an experimental study with an amyloid or tau targeting agent

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: [F-18]T807, 18F-AV-1451, LY3191748370 megabecquerel (MBq) IV single-dose	Drug	Flortaucipir PET Scan
PET Scanpositron emission tomography (PET) scan	Procedure or surgery	Flortaucipir PET Scan

Primary outcome

Primary Outcome 1: Diagnostic Performance of Individual Readers (NFT Score)
Time frame: at autopsy within 9 months of baseline scan
Sensitivity and specificity of 5 independent readers' interpretations of ante-mortem flortaucipir PET imaging for detection of a pattern of flortaucipir neocortical uptake that corresponds to neurofibrillary tangles (NFT) Score of B3 (Hyman et al., 2012; Montine et al., 2012). NFT B scores range from B0 (Braak Stage 0; no NFTs in the brain) to B3 (Braak Stage V/VI; widespread NFTs in the brain). Sensitivity and specificity are percentages that can range from 0 to 100%. The hypothesis tested was that, of the 5 independent imaging physicians, at least 3 will have the lower bounds of 2-sided 95% CIs ≥50%, for both sensitivity and specificity.
Primary Outcome 2: Diagnostic Performance of Individual Readers (NIA-AA Autopsy Diagnosis)
Time frame: at autopsy within 9 months of baseline scan
Sensitivity and specificity of 5 independent readers' interpretations of ante-mortem flortaucipir imaging for detection of a pattern of flortaucipir neocortical uptake that corresponds to high levels of Alzheimer's disease neuropathologic change (High ADNC) as defined by National Institute on Aging-Alzheimer's Association (NIA-AA) criteria. ADNC categories are None, Low, Intermediate and High, with High indicating the most severe level of AD-related pathology changes in the brain (Hyman et al., Alzheimers Dement. 2012 Jan;8(1):1-13). The hypothesis tested was that, of the 5 independent imaging physicians, at least 3 will have the lower bounds of 2-sided 95% CIs ≥50%, for both sensitivity and specificity.

3 secondary outcomes

Flortaucipir Diagnostic Performance (NFT Score)
Time frame: at autopsy within 9 months of baseline scan
Flortaucipir Diagnostic Performance (NIA-AA Autopsy Diagnosis)
Time frame: at autopsy within 9 months of baseline scan
Inter-Reader Agreement
Time frame: baseline scan

Results and safety

Results posted to the registry on 7 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Enrolled Cohort	156	64

Primary outcome: Primary Outcome 1: Diagnostic Performance of Individual Readers (NFT Score)

Time frame: at autopsy within 9 months of baseline scan. Number (95% Confidence Interval). Unit: percentage of cases correctly identified

Measure	Sensitivity of Flortaucipir vs Autopsy NFT Score B3 n = 39	Specificity of Flortaucipir vs Autopsy NFT Score <B3 n = 25
Reader 1	97.4 (86.8 to 99.5)	68.0 (48.4 to 82.8)
Reader 2	92.3 (79.7 to 97.3)	92.0 (75.0 to 97.8)
Reader 3	92.3 (79.7 to 97.3)	88.0 (70.0 to 95.8)
Reader 4	92.3 (79.7 to 97.3)	76.0 (56.6 to 88.5)
Reader 5	100 (91.0 to 100.0)	52.0 (33.5 to 70.0)

Population analysed: Autopsy cohort N=64. n=39 were truth positive for NFTs. n=25 were truth negative for NFTs.

Primary outcome: Primary Outcome 2: Diagnostic Performance of Individual Readers (NIA-AA Autopsy Diagnosis)

Time frame: at autopsy within 9 months of baseline scan. Number (95% Confidence Interval). Unit: percentage of cases correctly identified

Measure	Sensitivity of Flortaucipir vs NIA-AA Autopsy Diagnosis n = 38	Specificity of Flortaucipir vs NIA-AA Autopsy Diagnosis n = 26
Reader 1	97.5 (87.1 to 99.6)	65.4 (46.2 to 80.6)
Reader 2	95.0 (83.5 to 98.6)	92.3 (75.9 to 97.9)
Reader 3	95.0 (83.5 to 98.6)	88.5 (71.0 to 96.0)
Reader 4	95.0 (83.5 to 98.6)	76.9 (57.9 to 89.0)
Reader 5	100 (91.2 to 100.0)	50.0 (32.1 to 67.9)

Population analysed: Autopsy cohort N=64. n=38 were truth positive for NFTs. n=26 were truth negative for NFTs.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 9 months after flortaucipir scan, up to a total of 18 months if a subject was re-scanned per protocol. Other adverse events reported at 0.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Safety Analysis Population	3 of 156 (1.9%)	14 of 156 (9%)	73 of 156

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.
Background: PubMed 22265587Hyman BT, Phelps CH, Beach TG, Bigio EH, Cairns NJ, Carrillo MC, Dickson DW, Duyckaerts C, Frosch MP, Masliah E, Mirra SS, Nelson PT, Schneider JA, Thal DR, Thies B, Trojanowski JQ, Vinters HV, Montine TJ. National Institute on Aging-Alzheimer's Association guidelines for the neuropathologic assessment of Alzheimer's disease. Alzheimers Dement. 2012 Jan;8(1):1-13. doi: 10.1016/j.jalz.2011.10.007.
Background: PubMed 22101365Montine TJ, Phelps CH, Beach TG, Bigio EH, Cairns NJ, Dickson DW, Duyckaerts C, Frosch MP, Masliah E, Mirra SS, Nelson PT, Schneider JA, Thal DR, Trojanowski JQ, Vinters HV, Hyman BT; National Institute on Aging; Alzheimer's Association. National Institute on Aging-Alzheimer's Association guidelines for the neuropathologic assessment of Alzheimer's disease: a practical approach. Acta Neuropathol. 2012 Jan;123(1):1-11. doi: 10.1007/s00401-011-0910-3. Epub 2011 Nov 20.
Results publication: PubMed 32338734Fleisher AS, Pontecorvo MJ, Devous MD Sr, Lu M, Arora AK, Truocchio SP, Aldea P, Flitter M, Locascio T, Devine M, Siderowf A, Beach TG, Montine TJ, Serrano GE, Curtis C, Perrin A, Salloway S, Daniel M, Wellman C, Joshi AD, Irwin DJ, Lowe VJ, Seeley WW, Ikonomovic MD, Masdeu JC, Kennedy I, Harris T, Navitsky M, Southekal S, Mintun MA; A16 Study Investigators. Positron Emission Tomography Imaging With [18F]flortaucipir and Postmortem Assessment of Alzheimer Disease Neuropathologic Changes. JAMA Neurol. 2020 Jul 1;77(7):829-839. doi: 10.1001/jamaneurol.2020.0528.
Derived from this study: PubMed 32542468Pontecorvo MJ, Keene CD, Beach TG, Montine TJ, Arora AK, Devous MD Sr, Navitsky M, Kennedy I, Joshi AD, Lu M, Serrano GE, Sue LI, Intorcia AJ, Rose SE, Wilson A, Hellstern L, Coleman N, Flitter M, Aldea P, Fleisher AS, Mintun MA, Siderowf A. Comparison of regional flortaucipir PET with quantitative tau immunohistochemistry in three subjects with Alzheimer's disease pathology: a clinicopathological study. EJNMMI Res. 2020 Jun 15;10(1):65. doi: 10.1186/s13550-020-00653-x.

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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

31 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Flortaucipir F18 and PET Scan in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 31 sites in 2 countries.

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 8 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 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 31 sites in United States, Australia. 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 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?

Primary Outcome 1: Diagnostic Performance of Individual Readers (NFT Score) (time frame: at autopsy within 9 months of baseline scan). 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?

On the ClinicalTrials.gov record for NCT02516046, which also lists 4 linked publications.

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.