Phase 3
Completed N=156
18F-AV-1451 Autopsy Study
Source: ClinicalTrials.gov NCT02516046 ↗Enrolled (actual)
156
Serious AEs
1.9%
Results posted
Sep 2020
Primary outcomePrimary: Primary Outcome 1: Diagnostic Performance of Individual Readers (NFT Score) — 97.4; 68.0; 92.3; 92.0 percentage of cases correctly identified
◆ Published Evidence
Highly cited
444citations · ~74 / year
Positron Emission Tomography Imaging With [18F]flortaucipir and Postmortem Assessment of Alzheimer Disease Neuropathologic Changes.
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.
Linked Publications (2)
-
Positron Emission Tomography Imaging With [18F]flortaucipir and Postmortem Assessment of Alzheimer Disease Neuropathologic Changes.
-
Comparison of regional flortaucipir PET with quantitative tau immunohistochemistry in three subjects with Alzheimer's disease pathology: a clinicopathological study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Outcome 1: Diagnostic Performance of Individual Readers (NFT Score) |
97.4; 68.0; 92.3; 92.0; 92.3; 88.0 | — |
| PRIMARY Primary Outcome 2: Diagnostic Performance of Individual Readers (NIA-AA Autopsy Diagnosis) |
97.5; 65.4; 95.0; 92.3; 95.0; 88.5 | — |
| SECONDARY Flortaucipir Diagnostic Performance (NFT Score) |
92.3; 80.0 | — |
| SECONDARY Flortaucipir Diagnostic Performance (NIA-AA Autopsy Diagnosis) |
94.7; 80.8 | — |
| SECONDARY Inter-Reader Agreement |
0.79; 0.79; 0.79; 0.81; 0.96; 0.88 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02516046) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.