Clinical trial NCT02090855: Re-Read Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Neuritic Plaque Density Determined Postmortem
Official title: A Re-Read Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Neuritic Plaque Density Determined Postmortem.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Covance
name: H2O Clinical LLC
First posted: 2014-03-18
Enrollment: 108
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who had previously been dosed with Flutemetamol (18F) Injection and imaged in Study GE067-007.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Number of Abnormal Blinded Visual PET Image Interpretations.
timeFrame: Brain images will be assessed up to 1 year post subject's death.
measure: Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans
timeFrame: Brain images will be assessed up to 1 year post subject's death.
Secondary outcomes:
measure: Number of Blinded Visual PET Image Interpretations
timeFrame: Brain images will be assessed up to 1 year post subject's death.
measure: Specificity Percentage of Blinded Visual PET Image Interpretations
timeFrame: Brain images will be assessed up to 1 year post subject's death.
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Paul Sherwin, M.D.
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.