Back to results18F-AV-1451 High Resolution Autopsy Study
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-AV-1451
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer's Disease
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
Sites / Locations
- Banner Alzheimer's Institute
- University of California, San Francisco
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Autopsy Cohort
Arm Description
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.
Outcomes
Primary Outcome Measures
Relationship of 18F-AV-1451 scan and pathology
Correlation between 18F-AV-1451 standard uptake value ratio (SUVr) and neuropathology at autopsy.
Secondary Outcome Measures
Full Information
NCT ID
NCT02350634
First Posted
January 8, 2015
Last Updated
October 23, 2018
Sponsor
Avid Radiopharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02350634
Brief Title
18F-AV-1451 High Resolution Autopsy Study
Official Title
A High Resolution Autopsy Study Evaluating the Relationship of 18F-AV-1451 PET Imaging and Tau Pathology
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
May 18, 2018 (Actual)
Study Completion Date
May 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avid Radiopharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autopsy Cohort
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
18F-AV-1451
Other Intervention Name(s)
[F-18]T807
Intervention Description
Subjects will receive a single IV bolus injection of 370 megabecquerel (MBq)(10 millicurie [mCi]) of 18F-AV-1451.
Primary Outcome Measure Information:
Title
Relationship of 18F-AV-1451 scan and pathology
Description
Correlation between 18F-AV-1451 standard uptake value ratio (SUVr) and neuropathology at autopsy.
Time Frame
autopsy within 6 months of scan
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Banner Alzheimer's Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
12. IPD Sharing Statement
Learn more about this trial
18F-AV-1451 High Resolution Autopsy Study
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