The Feasibility of Florbetapir Quantitation

NCT ID: NCT01946243

Last Updated: 2015-06-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-04-30

Brief Summary

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The overall objective of the study is to assess the feasibility of implementing a quantitative process of florbetapir F 18 scan interpretation. The hypothesis is that the use of quantitative analysis will increase the accuracy of florbetapir F 18 scan interpretation.

Detailed Description

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Conditions

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Alzheimers Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Physician Readers

Physician readers will interpret Amyvid scans using qualitative analysis followed by the use of quantitation. No subjects will be exposed to Florbetapir F 18 as part of this study.

Group Type EXPERIMENTAL

Florbetapir F18

Intervention Type DRUG

No Florbetapir F 18 will be administered in this study.

Interventions

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Florbetapir F18

No Florbetapir F 18 will be administered in this study.

Intervention Type DRUG

Other Intervention Names

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Amyvid 18F-AV-45 florbetapir

Eligibility Criteria

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Inclusion Criteria

* Readers have undergone Amyvid reader training
* Readers have minimal experience with quantitation of amyloid PET scans

Exclusion Criteria

* Readers have previously been trained to quantitate amyloid PET scans
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Avid Radiopharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chief Medical Officer

Role: STUDY_DIRECTOR

Avid Radiopharmaceuticals, Inc.

Locations

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Research Site

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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18F-AV-45-QP01

Identifier Type: -

Identifier Source: org_study_id

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