Evaluation of Reader Training Processes

NCT ID: NCT02051790

Last Updated: 2015-09-28

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

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-08-31

Brief Summary

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This study is designed to evaluate the agreement between florbetapir F 18 scan interpretation in the clinic and by expert readers.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Clinical Practice Scans

Approximately 250 florbetapir F 18 scans and final scan reports interpreted in a clinical setting will be collected from physicians across the country. These results will then be compared to expert panel interpretations for the same scans.

Group Type EXPERIMENTAL

florbetapir F 18

Intervention Type DRUG

No study drug will be administered in this study - scans previously acquired in the course of clinical practice.

Interventions

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florbetapir F 18

No study drug will be administered in this study - scans previously acquired in the course of clinical practice.

Intervention Type DRUG

Other Intervention Names

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18F-AV-45 Amyvid florbetapir

Eligibility Criteria

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Inclusion Criteria

\- Scan obtained for clinical reasons

Exclusion Criteria

\- None
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

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-RTP01

Identifier Type: -

Identifier Source: org_study_id

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