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• W2766202041 abstract "Several potential anti-amyloid therapies for Alzheimer's disease (AD) are associated with increased incidence of amyloid-related imaging abnormalities-hemorrhage/hemosiderin deposition (ARIA-H), visible as hypointensities on T2*-weighted gradient echo sequences. Subjects with ARIA-H counts above a certain threshold are recommended to be excluded from clinical trials. Large multi-site AD trials include both 1.5T and 3T MRI scanners. Implementation of similar sequence parameters (matrix, slice thickness, echo time) across these field strengths results in decreased detection sensitivity for ARIA-H at 1.5T versus 3T. To minimize this bias, sequence parameters can be optimized to maximize consistency across field strengths. In this analysis, we compare baseline prevalence of ARIA-H detected at 1.5T versus 3T scanners, using sequence parameters harmonized across field strengths, in 2137 subjects from EXPEDITION and EXPEDITION2 trials. MR imaging was obtained at 221 imaging centers that were qualified for MRI standardization. MRIs were conducted on imaging platforms including three MR vendors (GE, Philips and Siemens) and one of two MRI field strengths, 1.5 or 3 Tesla (Table 1). MRI protocol was harmonized across manufacturer and field strength by adapting echo time to field strength. These trials predated specific FDA guidance that did not take into account differing field strengths (slice thickness ≤ 1.5 cm, TE ≥ 20ms). MRI scans were centrally read by experienced neuro-radiologists and the number of ARIA-H was recorded as 0, 1, 2–5, 6–10 or >10. Superficial siderosis was not systematically collected so in this analysis, ARIA-H refers to microhemorrhage (< 10mm). More study subjects were scanned on 1.5T compared with 3T scanners. The prevalence of ARIA-H at baseline was 18.5% and 20.6% on 1.5T and 3T scanners, respectively. The prevalence of ARIA-H across categories was similar between 1.5T and 3T scanners with the highest prevalence in patients with 1 ARIA-H at both field strengths (Table 1). If care is taken to design sequence acquisition parameters to obtain a similar sensitivity to ARIA-H at 1.5T and 3T, a consistent prevalence and distribution of ARIA-H across these field strengths can be obtained, removing a notable source of bias in enrollment and safety monitoring." @default.
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• W2766202041 date "2017-07-01" @default.
• W2766202041 modified "2023-09-28" @default.
• W2766202041 title "[IC-P-042]: COMPARISON OF BASELINE ARIA-H PREVALENCE AT 1.5T AND 3T MRI FIELD STRENGTHS IN A MULTI-SITE GLOBAL CLINICAL TRIAL WITH A COHORT OF 2,137 AD SUBJECTS" @default.
• W2766202041 doi "https://doi.org/10.1016/j.jalz.2017.06.2314" @default.
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