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

General Electric (GE)

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease; Mild Cognitive Impairment

Treatments: Drug: [18F]Flutemetamol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01672827

GE-067-021

Details and patient eligibility

About

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

Enrollment: 276 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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276 participants in 1 patient group

[18F]Flutemetamol

Experimental group

Treatment:

Drug: [18F]Flutemetamol