18F-AV-1451 High Resolution Autopsy Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-26

Study Completion Date

2017-06-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Autopsy Cohort

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.

Group Type EXPERIMENTAL

Flortaucipir F18

Intervention Type DRUG

Subjects will receive a single IV bolus injection of 370 megabecquerel (MBq) (10 millicurie \[mCi\]) of flortaucipir.

Interventions

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Flortaucipir F18

Subjects will receive a single IV bolus injection of 370 megabecquerel (MBq) (10 millicurie \[mCi\]) of flortaucipir.

Intervention Type DRUG

Other Intervention Names

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[F-18]T807 18F-AV-1451

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No