Phase 1
N=3
18F-AV-1451 High Resolution Autopsy Study
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02350634 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Relationship of Flortaucipir Scan and Pathology - Whole Cortical Composite Region — 0.429 Correlation coefficient — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Flortaucipir F18 (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Avid Radiopharmaceuticals
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relationship of Flortaucipir Scan and Pathology - Whole Cortical Composite Region |
0.429 | <0.001 sig |
| PRIMARY Relationship of Flortaucipir Scan and Pathology - Frontal Composite Region |
0.681 | <0.001 sig |
| PRIMARY Relationship of Flortaucipir Scan and Pathology - Parietal Composite Region |
0.644 | 0.00278 sig |
| PRIMARY Relationship of Flortaucipir Scan and Pathology - Cingulate Composite Region |
0.437 | 0.12 |
| PRIMARY Relationship of Flortaucipir Scan and Pathology - Temporal Composite Region |
0.324 | 0.0712 |
| PRIMARY Relationship of Flortaucipir Scan and Pathology - Occipital Composite Region |
0.564 | 0.0958 |
| PRIMARY Relationship of Flortaucipir Scan and Pathology - Limbic Composite Region |
-0.189 | 0.558 |
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.
Eligibility Criteria
Inclusion Criteria
- Projected life expectancy ≤ 6 months
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02350634). 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.