18F-AV-1451 High Resolution Autopsy Study

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: 18F-AV-1451

• Registration Number: NCT02350634
• Lead Sponsor: Avid Radiopharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-08
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-01-30
• Study Start: 2015-06
• Primary Completion: 2018-05-18
• Study Completion: 2018-05-18
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-23
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autopsy Cohort	18F-AV-1451	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 18F-AV-1451.

Primary Outcome Measures

Name	Time	Method
Relationship of 18F-AV-1451 scan and pathology	autopsy within 6 months of scan	Correlation between 18F-AV-1451 standard uptake value ratio (SUVr) and neuropathology at autopsy.

Trial Locations

Locations (2)

Banner Alzheimer's Institute; 🇺🇸 Phoenix, Arizona, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States