Clinical trial NCT01165554: Positron Emission Tomography (PET) Imaging of Brain Amyloid Compared to Post-Mortem Levels
Official title: A Principal Open-Label Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Amyloid Levels Determined Post-Mortem
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Brain Fibrillarab Levels
Keywords: Amyloid
PET-Positron Emission Tomography
SUVR-Standard uptake value ratios
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: i3 Statprobe
name: Covance
First posted: 2010-07-20
Enrollment: 203
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β.
timeFrame: Post flutemetamol administration.
Secondary outcomes:
measure: Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images.
timeFrame: Post Flutemetamol administrations
measure: Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference.
timeFrame: Post flutemetamol administration.
measure: Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference.
timeFrame: Post flutemetamol administration.
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Paul Sherwin, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.