Re-Read Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Neuritic Plaque Density Determined Postmortem

A Re-Read Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Neuritic Plaque Density Determined Postmortem.

Data from subjects who had previously been dosed with Flutemetamol (18F) Injection and imaged in Study GE-067-007, and who died on or before 10 June 2013, will be analyzed. The PET brain images previously obtained in Study GE-067-007 will be interpreted visually in randomized by 5 independent readers who are blinded to all other subject information, and the images will be classified as abnormal (positive for abnormal neuritic plaque density) or normal (negative for abnormal neuritic plaque density). The numbers of images in each category will be used to calculate sensitivity and specificity.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • GE Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who had previously been dosed with Flutemetamol (18F) Injection and imaged in Study GE067-007.

Description

Inclusion Criteria:

• The subject was enrolled in prior Study GE067-007.
• The subject died on or before 10 June 2013.
• The subject's brain is judged to be of suitable quality for analysis, including all regions necessary for analysis.

Exclusion Criteria:

• Not Applicable

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Flutemetamol (18F); There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Abnormal Blinded Visual PET Image Interpretations.	Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program.	Brain images will be assessed up to 1 year post subject's death.
Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans	Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program.	Brain images will be assessed up to 1 year post subject's death.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Blinded Visual PET Image Interpretations	Specificity of blinded visual image interpretations according to neuropathological criteria.	Brain images will be assessed up to 1 year post subject's death.
Specificity Percentage of Blinded Visual PET Image Interpretations	Specificity of blinded visual image interpretations according to neuropathological criteria, which is defined as the neuritic plaque density, neurofibriilary tangles and vasculpoathy in the brain.	Brain images will be assessed up to 1 year post subject's death.

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: Covance; H2O Clinical LLC

Publications and helpful links

General Publications

• Thal DR, Ronisz A, Tousseyn T, Rijal Upadhaya A, Balakrishnan K, Vandenberghe R, Vandenbulcke M, von Arnim CAF, Otto M, Beach TG, Lilja J, Heurling K, Chakrabarty A, Ismail A, Buckley C, Smith APL, Kumar S, Farrar G, Walter J. Different aspects of Alzheimer's disease-related amyloid beta-peptide pathology and their relationship to amyloid positron emission tomography imaging and dementia. Acta Neuropathol Commun. 2019 Nov 14;7(1):178. doi: 10.1186/s40478-019-0837-9. Erratum In: Acta Neuropathol Commun. 2020 Aug 3;8(1):121.
• Thal DR, Beach TG, Zanette M, Lilja J, Heurling K, Chakrabarty A, Ismail A, Farrar G, Buckley C, Smith APL. Estimation of amyloid distribution by [18F]flutemetamol PET predicts the neuropathological phase of amyloid beta-protein deposition. Acta Neuropathol. 2018 Oct;136(4):557-567. doi: 10.1007/s00401-018-1897-9. Epub 2018 Aug 19.
• Ikonomovic MD, Buckley CJ, Heurling K, Sherwin P, Jones PA, Zanette M, Mathis CA, Klunk WE, Chakrabarty A, Ironside J, Ismail A, Smith C, Thal DR, Beach TG, Farrar G, Smith AP. Post-mortem histopathology underlying beta-amyloid PET imaging following flutemetamol F 18 injection. Acta Neuropathol Commun. 2016 Dec 12;4(1):130. doi: 10.1186/s40478-016-0399-z.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: March 11, 2014
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (Estimate): March 18, 2014

Study Record Updates

• Last Update Posted (Actual): March 27, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Plaque, Amyloid
• Other Study ID Numbers: GE-067-026