Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images

NCT ID: NCT01672827

Last Updated: 2014-01-24

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

PHASE3

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-08-31

Brief Summary

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To Evaluate the Effectiveness of an Electronic Training Program for Orienting and Interpreting \[18F\]flutemetamol Positron Emission Tomography (PET) Images.

Detailed Description

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Conditions

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Alzheimer's Disease Mild Cognitive Impairment

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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[18F]Flutemetamol

Group Type EXPERIMENTAL

[18F]Flutemetamol

Intervention Type DRUG

No drug is administered in this intervention. These are scanned images being reviewed, previously acquired in various GE-067 studies.

Interventions

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[18F]Flutemetamol

No drug is administered in this intervention. These are scanned images being reviewed, previously acquired in various GE-067 studies.

Intervention Type DRUG

Other Intervention Names

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Flutemetamol

Eligibility Criteria

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Inclusion Criteria

* Subject received a dose of Flutemetamol F 18 Injection ranging from approximately 185 MBq to approximately 370 MBq.
* The subject was classified as one of the following:

1. End-of-life subject who expired and underwent brain autopsy, with histochemical (HC) confirmation of brain amyloid status.
2. Subject with known/suspected normal pressure hydrocephalus (NPH) who underwent brain biopsy, with HC confirmation of brain amyloid status.
3. Elderly healthy volunteer (age ≥55).
4. Young healthy volunteer (age ≤40).
5. Subject with probable Alzheimer Disease (pAD).
6. Subject with amnestic Mild Cognitive Impairment (aMCI).

Exclusion Criteria

* Not Applicable
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Sherwin, MD

Role: STUDY_CHAIR

GE Healthcare

Other Identifiers

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GE-067-021

Identifier Type: -

Identifier Source: org_study_id

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