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

NCT01672827 | Completed Phase 3 Results

• 1 other identifier: GE-067-021
• Study Type: interventional
• Target: 276
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Alzheimer's Disease; Mild Cognitive Impairment

Keywords

Alzheimer's Disease; Mild Cognitive Impairment; Positron Emission Tomography (PET); PET Images

Outcome Measures

Primary Outcomes (2)

• Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images.

  Statistical analysis of summary of the blinded visual PET Image Interpretations without Anatomic Images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study. These Readers examined the PET images for evidence of amyloid plaque.

  Post flutemetamol administration

• Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images.

  Statistical analysis of summary of sensitivity of blinded visual PET image interpretations without anatomic images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study.These Readers examined the PET images for evidence of amyloid plaque.

  Post flutemetamol administration

Secondary Outcomes (1)

• Inter-Reader Agreement of PET Images Without Anatomic Images

  Post Flutemetamol Injection

Study Arms (1)

[18F]Flutemetamol

EXPERIMENTAL

Drug: [18F]Flutemetamol

Interventions

[18F]Flutemetamol DRUG

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

Also known as: Flutemetamol

[18F]Flutemetamol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Not Applicable

Sponsors & Collaborators

• GE Healthcare: lead

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

flutemetamol

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Results Point of Contact

• Title: Paul Sherwin, M.D.
• Organization: GE Healthcare

paulsherwin@ge.com

1-609-514-6820

Study Officials

• Paul Sherwin, MD

  GE Healthcare

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 27, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 24, 2014
• Results First Posted: December 19, 2013

Record last verified: 2013-12