18F-AV-1451 High Resolution Autopsy Study

Phase 1

Completed

Conditions: Alzheimer's Disease

Interventions: Drug: Flortaucipir F18

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

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	Flortaucipir F18	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 flortaucipir F18.

Primary Outcome Measures

Name	Time	Method
Relationship of Flortaucipir Scan and Pathology - Whole Cortical Composite Region	autopsy within 6 months of scan	Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of whole cortical global quantitation of the PET scan from 82 FreeSurfer-defined regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Relationship of Flortaucipir Scan and Pathology - Frontal Composite Region	autopsy within 6 months of scan	Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of frontal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Relationship of Flortaucipir Scan and Pathology - Parietal Composite Region	autopsy within 6 months of scan	Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of parietal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Relationship of Flortaucipir Scan and Pathology - Cingulate Composite Region	autopsy within 6 months of scan	Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of cingulate composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Relationship of Flortaucipir Scan and Pathology - Temporal Composite Region	autopsy within 6 months of scan	Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of temporal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Relationship of Flortaucipir Scan and Pathology - Occipital Composite Region	autopsy within 6 months of scan	Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of occipital composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Relationship of Flortaucipir Scan and Pathology - Limbic Composite Region	autopsy within 6 months of scan	Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of limbic composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (2): Banner Alzheimer's Institute
🇺🇸
Phoenix, Arizona, United States
University of California, San Francisco
🇺🇸
San Francisco, California, United States
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States