The Feasibility of Florbetapir Quantitation in Europe

NCT ID: NCT02107599

Last Updated: 2015-07-09

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

2014-03-31

Study Completion Date

2014-05-31

Brief Summary

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This study will evaluate whether the addition of quantitation as an adjunct to visual interpretations significantly improves the accuracy of Amyvid scan interpretation.

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

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(18F) as part of this study.

Group Type EXPERIMENTAL

Florbetapir (18F)

Intervention Type DRUG

No Florbetapir (18F) will be administered in this study.

Interventions

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Florbetapir (18F)

No Florbetapir (18F) will be administered in this study.

Intervention Type DRUG

Other Intervention Names

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Florbetapir F 18 Amyvid 18F-AV-45

Eligibility Criteria

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Inclusion Criteria

* Readers have undergone Amyvid reader training
* Readers have not more than 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

Leiden, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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18F-AV-45-QP02

Identifier Type: -

Identifier Source: org_study_id

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