Phase 3
N=156
18F-AV-1451 Autopsy Study
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02516046 ↗Enrolled (actual)
156
Serious AEs
1.9%
Results posted
Sep 2020
Primary outcome: Primary: Primary Outcome 1: Diagnostic Performance of Individual Readers (NFT Score) — 97.4; 68.0; 92.3; 92.0 percentage of cases correctly identified
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Flortaucipir F18 (Drug); PET Scan (Procedure)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Avid Radiopharmaceuticals
- Primary completion
- Jun 2018
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 | — |
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.
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). 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.