Amyloid-related imaging abnormalities from trials of solanezumab for Alzheimer's disease

Abstract Introduction Solanezumab, a humanized monoclonal antibody that binds soluble amyloid beta peptide, is being developed for treatment of Alzheimer's disease (AD). Methods Patients (n = 2042) with mild and moderate AD were randomized 1:1 to 400-mg solanezumab or placebo infusion every 4 w...

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Bibliographic Details
Published in:Alzheimer's & dementia : diagnosis, assessment & disease monitoring assessment & disease monitoring, 2016, Vol.2 (1), p.75-85
Main Authors: Carlson, Christopher, Siemers, Eric, Hake, Ann, Case, Michael, Hayduk, Roza, Suhy, Joyce, Oh, Joonmi, Barakos, Jerome
Format: Article
Language:English
Subjects:
Alzheimer's disease
Amyloid-related imaging abnormalities
Asymptomatic
Clinical trials
Dementia
Edema
Headaches
Magnetic resonance imaging
Nausea
Neuroimaging
Neurology
Older people
Other
Patients
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Summary:Abstract Introduction Solanezumab, a humanized monoclonal antibody that binds soluble amyloid beta peptide, is being developed for treatment of Alzheimer's disease (AD). Methods Patients (n = 2042) with mild and moderate AD were randomized 1:1 to 400-mg solanezumab or placebo infusion every 4 weeks for 80 weeks and 1457 patients entered an open-label extension. Magnetic resonance imaging scans monitored for amyloid-related imaging abnormalities-edema/effusion (ARIA-E) and amyloid-related imaging abnormalities-hemorrhage/hemosiderin deposition. Results Sixteen patients (solanezumab, n = 11; placebo, n = 5) developed ARIA-E during the double-blind phase, and 7 patients developed ARIA-E during the open-label extension as of July 31, 2014. Unique cases are discussed including solanezumab patients who were given solanezumab, while ARIA-E was present and a patient who developed ARIA-E during placebo treatment and again during solanezumab treatment. Discussion Asymptomatic ARIA-E was detected in solanezumab-treated and placebo-treated AD patients. ARIA-E occurs infrequently during solanezumab and placebo treatments but may occur repeatedly in some patients.
ISSN:2352-8729
2352-8729
DOI:10.1016/j.dadm.2016.02.004