Alzheimer's DiseasePhase 1NCT02350634

18F-AV-1451 High Resolution Autopsy Study

A Phase 1 study testing Flortaucipir F18 in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 2 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

The study is designed to examine the relationship between imaging results detected on a 18F-AV-1451 PET scan and pathology found at autopsy within six months of imaging. Read more about this study

Who is it for?: Ages 60 to 89 years
Conditions the study is for: Alzheimer's Disease
What is being tested?: Flortaucipir F18
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 2 sitesUnited States
Study dates: 26 Nov 2016to 16 Jun 2017
Phase: Phase 1
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 60 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Projected life expectancy ≤ 6 months

Who cannot join

Primary brain tumor, known metastases to the brain, central nervous system lymphoma
Major, focal structural brain lesion
Aggressively being treated with life sustaining measures
Clinically significant infectious disease
History of risk factors for Torsades de Pointes or are currently taking medication known to cause QT prolongation
Have received or participated in a trial with investigational medications in the past 30 days
Females of childbearing potential who are pregnant or not using adequate contraception

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Banner Alzheimer's Institute
Phoenix, Arizona, 85006
University of California, San Francisco
San Francisco, California, 94121

Other trials in United States

About this study

Official title: A High Resolution Autopsy Study Evaluating the Relationship of 18F-AV-1451 PET Imaging and Tau Pathology

The study is designed to examine the relationship between imaging results detected on a 18F-AV-1451 PET scan and pathology found at autopsy within six months of imaging.

Conditions: Alzheimer's Disease
Being tested: Flortaucipir 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.

Flortaucipir F18Drug
Also called [F-18]T807, 18F-AV-1451
Subjects will receive a single IV bolus injection of 370 megabecquerel (MBq) (10 millicurie [mCi]) of flortaucipir.

Study groups in NCT02350634
Study group	Role	What they receive
Autopsy Cohort	Experimental	End-of-life subjects (life expectancy < 6 months) consenting to brain donation at autopsy. Subjects will receive a single IV bolus injection of 370 MBq(10 mCi) of flortaucipir F18. Receives: Drug: Flortaucipir F18

What is being measured

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

Relationship of Flortaucipir Scan and Pathology - Whole Cortical Composite Region
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of whole cortical global quantitation of the PET scan from 82 FreeSurfer-defined regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Measured: autopsy within 6 months of scan
Relationship of Flortaucipir Scan and Pathology - Frontal Composite Region
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of frontal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Measured: autopsy within 6 months of scan
Relationship of Flortaucipir Scan and Pathology - Parietal Composite Region
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of parietal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Measured: autopsy within 6 months of scan
Relationship of Flortaucipir Scan and Pathology - Cingulate Composite Region
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of cingulate composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Measured: autopsy within 6 months of scan
Relationship of Flortaucipir Scan and Pathology - Temporal Composite Region
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of temporal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Measured: autopsy within 6 months of scan
Relationship of Flortaucipir Scan and Pathology - Occipital Composite Region
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of occipital composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Measured: autopsy within 6 months of scan
Relationship of Flortaucipir Scan and Pathology - Limbic Composite Region
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of limbic composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Measured: autopsy within 6 months of scan

Timeline

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

26 Nov 201616 Jun 2017

First posted30 Jan 2015 (estimated)
Study start26 Nov 2016
Primary completion16 Jun 2017
Study completion16 Jun 2017

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 1
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02350634
Sponsor's protocol ID: 18F-AV-1451-A13
Status last verified: May 2025
First submitted: 8 Jan 2015
Last updated: 10 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ushizima D, Chen Y, Alegro M, Ovando D, Eser R, Lee W, Poon K, Shankar A, Kantamneni N, Satrawada S, Junior EA, Heinsen H, Tosun D, Grinberg LT. Deep learning for Alzheimer's disease: Mapping large-scale histological tau protein for neuroimaging biomarker validation. Neuroimage. 2022 Mar;248:118790. doi: 10.1016/j.neuroimage.2021.118790. Epub 2021 Dec 20.
PubMed 34933123

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A High Resolution Autopsy Study Evaluating the Relationship of 18F-AV-1451 PET Imaging and Tau Pathology
ClinicalTrials.gov ID: NCT02350634
Acronym / sponsor ID: 18F-AV-1451-A13
Conditions: Alzheimer's Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 3 participants (actual)
Lead sponsor: Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 26 Nov 2016 (actual)
Primary completion: 16 Jun 2017 (actual)
Study completion: 16 Jun 2017 (actual)
First posted: 30 Jan 2015 (estimated)
Results: Posted 10 Jun 2025

Clinical summary

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

The study is designed to examine the relationship between imaging results detected on a 18F-AV-1451 PET scan and pathology found at autopsy within six months of imaging.

Study design

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

Arm	Type	Receives
Autopsy Cohort	Experimental	Drug: Flortaucipir F18End-of-life subjects (life expectancy < 6 months) consenting to brain donation at autopsy. Subjects will receive a single IV bolus injection of 370 MBq(10 mCi) of flortaucipir F18.

Who may qualify

Ages: 60 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Projected life expectancy ≤ 6 months

Key exclusion criteria (7 listed)

Primary brain tumor, known metastases to the brain, central nervous system lymphoma
Major, focal structural brain lesion
Aggressively being treated with life sustaining measures
Clinically significant infectious disease
History of risk factors for Torsades de Pointes or are currently taking medication known to cause QT prolongation

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-1451Subjects will receive a single IV bolus injection of 370 megabecquerel (MBq) (10 millicurie [mCi]) of flortaucipir.	Drug	Autopsy Cohort

Primary outcome

Relationship of Flortaucipir Scan and Pathology - Whole Cortical Composite Region
Time frame: autopsy within 6 months of scan
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of whole cortical global quantitation of the PET scan from 82 FreeSurfer-defined regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Relationship of Flortaucipir Scan and Pathology - Frontal Composite Region
Time frame: autopsy within 6 months of scan
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of frontal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Relationship of Flortaucipir Scan and Pathology - Parietal Composite Region
Time frame: autopsy within 6 months of scan
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of parietal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Relationship of Flortaucipir Scan and Pathology - Cingulate Composite Region
Time frame: autopsy within 6 months of scan
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of cingulate composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Relationship of Flortaucipir Scan and Pathology - Temporal Composite Region
Time frame: autopsy within 6 months of scan
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of temporal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Relationship of Flortaucipir Scan and Pathology - Occipital Composite Region
Time frame: autopsy within 6 months of scan
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of occipital composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Relationship of Flortaucipir Scan and Pathology - Limbic Composite Region
Time frame: autopsy within 6 months of scan
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of limbic composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.

Results and safety

Results posted to the registry on 10 Jun 2025, 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	3	2

Primary outcome: Relationship of Flortaucipir Scan and Pathology - Whole Cortical Composite Region

Time frame: autopsy within 6 months of scan. Number. Unit: Correlation coefficient

Measure	Autopsy Cohort n = 2
Value	0.429

Autopsy Cohort: Correlation coefficient: 0.429, p <0.001, Spearman's Rank Order Correlation test

Population analysed: One subject did not come to autopsy within 6 months of the flortaucipir scan.

Primary outcome: Relationship of Flortaucipir Scan and Pathology - Frontal Composite Region

Time frame: autopsy within 6 months of scan. Number. Unit: Correlation coefficient

Measure	Autopsy Cohort n = 2
Value	0.681

Autopsy Cohort: Correlation coefficient: 0.681, p <0.001, Spearman's Rank Order Correlation test

Population analysed: One subject did not come to autopsy within 6 months of the flortaucipir scan.

Primary outcome: Relationship of Flortaucipir Scan and Pathology - Parietal Composite Region

Time frame: autopsy within 6 months of scan. Number. Unit: Correlation coefficient

Measure	Autopsy Cohort n = 2
Value	0.644

Autopsy Cohort: Correlation coefficient: 0.644, p = 0.00278, Spearman's Rank Order Correlation test

Population analysed: One subject did not come to autopsy within 6 months of the flortaucipir scan.

Primary outcome: Relationship of Flortaucipir Scan and Pathology - Cingulate Composite Region

Time frame: autopsy within 6 months of scan. Number. Unit: Correlation coefficient

Measure	Autopsy Cohort n = 2
Value	0.437

Autopsy Cohort: Correlation coefficient: 0.437, p = 0.12, Spearman's Rank Order Correlation test

Population analysed: One subject did not come to autopsy within 6 months of the flortaucipir scan.

Adverse events

Time frame: Up to a total of 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Safety Analysis Cohort	0 of 3 (0%)	0 of 3 (0%)	2 of 3

Limitations and caveats (from the sponsor): The original intent of the protocol was to assess relationships between in vivo flortaucipir PET signal and tau pathology at a higher resolution than the Free Surfer ROIs, such as voxel-wise. Higher resolution could potentially offer more precise insights into tracer distribution patterns. However, the analysis was constrained by challenges in acquiring a complete set of pathology images from collaborators and unanticipated technical challenges in image processing.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 34933123Ushizima D, Chen Y, Alegro M, Ovando D, Eser R, Lee W, Poon K, Shankar A, Kantamneni N, Satrawada S, Junior EA, Heinsen H, Tosun D, Grinberg LT. Deep learning for Alzheimer's disease: Mapping large-scale histological tau protein for neuroimaging biomarker validation. Neuroimage. 2022 Mar;248:118790. doi: 10.1016/j.neuroimage.2021.118790. Epub 2021 Dec 20.

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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.

Medical Director study director

Avid Radiopharmaceuticals

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Flortaucipir F18 in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 2 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 1 inclusion and 7 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 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 10 Jun 2025). 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?

Relationship of Flortaucipir Scan and Pathology - Whole Cortical Composite Region (time frame: autopsy within 6 months of scan). The study lists 7 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 NCT02350634, 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 10 Jun 2025.