Completed

A Study to Evaluate the Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images.

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What is being tested

[18F]Flutemetamol

Drug
Who is being recruted

Mental Disorders+8

+ Brain Diseases

+ Central Nervous System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 3
Interventional
Study Start: July 2012
See protocol details

Summary

Principal SponsorGE Healthcare
Last updated: January 24, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01672827
Principal SponsorGE Healthcare
Last updated: January 24, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

276 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersBrain DiseasesCentral Nervous System DiseasesCognition DisordersDementiaNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersTauopathiesAlzheimer DiseaseCognitive Dysfunction

Criteria

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: End-of-life subject who expired and underwent brain autopsy, with histochemical (HC) confirmation of brain amyloid status. Subject with known/suspected normal pressure hydrocephalus (NPH) who underwent brain biopsy, with HC confirmation of brain amyloid status. Elderly healthy volunteer (age ≥55). Young healthy volunteer (age ≤40). Subject with probable Alzheimer Disease (pAD). Subject with amnestic Mild Cognitive Impairment (aMCI). Exclusion Criteria: Not Applicable

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers