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

NCT02090855 | Completed Results

• 1 other identifier: GE-067-026
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Number of Blinded Visual PET Image Interpretations

  Brain images will be assessed up to 1 year post subject's death.

• Specificity Percentage of Blinded Visual PET Image Interpretations

  Brain images will be assessed up to 1 year post subject's death.

Study Arms (1)

Flutemetamol (18F)

There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007.

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Not Applicable

Sponsors & Collaborators

• GE Healthcare: lead
• Covance: collaborator
• H2O Clinical LLC: collaborator

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

Related Publications (5)

• Kim SJ, Jang H, Yoo H, Na DL, Ham H, Kim HJ, Kim JP, Farrar G, Moon SH, Seo SW. Clinical and Pathological Validation of CT-Based Regional Harmonization Methods of Amyloid PET. Clin Nucl Med. 2024 Jan 1;49(1):1-8. doi: 10.1097/RLU.0000000000004937. Epub 2023 Nov 29.

  PMID: 38048354 DERIVED

• Tome SO, Tsaka G, Ronisz A, Ospitalieri S, Gawor K, Gomes LA, Otto M, von Arnim CAF, Van Damme P, Van Den Bosch L, Ghebremedhin E, Laureyssen C, Sleegers K, Vandenberghe R, Rousseau F, Schymkowitz J, Thal DR. TDP-43 pathology is associated with increased tau burdens and seeding. Mol Neurodegener. 2023 Sep 30;18(1):71. doi: 10.1186/s13024-023-00653-0.

  PMID: 37777806 DERIVED

• 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.

  PMID: 31727169 DERIVED

• 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.

  PMID: 30123935 DERIVED

• 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.

  PMID: 27955679 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

The Clinical Trials NCT number is 01165554 for GE Healthcare study, GE-067-007.

Results Point of Contact

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

Paul.Sherwin@ge.com

1-609-514-6489

Study Officials

• Paul Sherwin, M.D.

  GE Healthcare

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: March 18, 2014
• Study Start: September 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 27, 2017
• Results First Posted: August 27, 2014

Record last verified: 2017-02

Locations

US (1)