18F-AV-1451 High Resolution Autopsy Study

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350634
• Other study ID #: 18F-AV-1451-A13
• Status: Completed
• Phase: Phase 1
• Start date: June 2015
• Est. completion date: May 18, 2018

Study information

• Verified date: October 2018
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: May 18, 2018
• Est. primary completion date: May 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• 18F-AV-1451
Subjects will receive a single IV bolus injection of 370 megabecquerel (MBq)(10 millicurie [mCi]) of 18F-AV-1451.

Locations

Country	Name	City	State
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship of 18F-AV-1451 scan and pathology	Correlation between 18F-AV-1451 standard uptake value ratio (SUVr) and neuropathology at autopsy.	autopsy within 6 months of scan