Positron Emission Tomography (PET) Imaging of Brain Amyloid Compared to Post-Mortem Levels

NCT01165554 | Completed Phase 3 Results

• 1 other identifier: GE-067-007
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the level of association between quantitative regional estimates of brain uptake of \[18F\]flutemetamol and quantitative immunohistochemical regional estimates of brain levels of amyloid estimated from post-mortem analysis of corresponding brain tissue samples.

Conditions

Brain Fibrillarab Levels

Keywords

Amyloid; PET-Positron Emission Tomography; SUVR-Standard uptake value ratios

Outcome Measures

Primary Outcomes (1)

• The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β.

  A calculation used to assess Sensitivity was (Number of Blinded Reads determined abnormal by Reader "N") divided by the (Total number of abnormal participants). Blinded visual interpretations of \[18F\]flutemetamol Positron Emission Tomography (PET) images without anatomic brain images for detecting brain fibrillar amyloid β.

  Post flutemetamol administration.

Secondary Outcomes (3)

• Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images.

  Post Flutemetamol administrations

• Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference.

  Post flutemetamol administration.

• Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference.

  Post flutemetamol administration.

Study Arms (1)

[18F] Flutemetamol

EXPERIMENTAL

Drug: [18F] Flutemetamol

Interventions

[18F] Flutemetamol DRUG

Flutemetamol (18F) Injection, 111 to 370 MBq (3 to 10 mCi), single intravenous injection.

Also known as: AH110690

[18F] Flutemetamol

Eligibility Criteria

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

You may qualify if:

• The subject has a short life expectancy (approximately 1 year or less) as estimated by the Investigator.
• The subject is 70 years of age or older if cognitively normal, or 55 years of age or older if terminal because of dementia.
• The subject's general health is adequate to undergo the study procedures.

You may not qualify if:

• The subject has a contraindication for PET.
• The subject has a known or suspected hypersensitivity/allergy to \[18F\]flutemetamol or to any of the excipients.
• The subject is unable to tolerate or cooperate with study procedures.

Sponsors & Collaborators

• GE Healthcare: lead
• i3 Statprobe: collaborator
• Covance: 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

MeSH Terms

Conditions

Alzheimer Disease

Interventions

flutemetamol

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Paul Sherwin
• Organization: GE Healthcare

paulsherwin@ge.com

1-609-514-6820

Study Officials

• Paul Sherwin, MD, PhD

  GE Healthcare

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: July 20, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 4, 2013
• Results First Posted: December 4, 2013

Record last verified: 2013-11

Locations

US (1)