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. 2016 Mar 2:2:75-85.
doi: 10.1016/j.dadm.2016.02.004. eCollection 2016.

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

Christopher Carlson  1 , Eric Siemers  1 , Ann Hake  1 , Michael Case  1 , Roza Hayduk  2 , Joyce Suhy  3 , Joonmi Oh  3 , Jerome Barakos  4
Affiliations

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

Christopher Carlson et al. Alzheimers Dement (Amst). .

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.

Keywords: Alzheimer's disease; Amyloid-related imaging abnormalities; Clinical trials.

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Figures

Fig. 1
Fig. 1
(A) Baseline distribution of ARIA-H by treatment. ARIA-H was categorized as 0, 1, 2 to 5, 6 to 10, and >10, (B) Categorical increases in ARIA-H. Categorical increases were determined by the number of increases between categories 1, 2 to 5, 6 to 10, >10, and > 10 with further increases.
Fig. 2
Fig. 2
FLAIR images from patient P. (A) 12 weeks, (B) 28 weeks, (C) 52 weeks, (D) 80 weeks. Red arrows indicate areas of ARIA-E.
Fig. 3
Fig. 3
FLAIR images from patient B. EXPEDITION (A) 12 weeks, and Unscheduled 1, 36 days; EXPEDITION-EXT (B) 52 weeks, and Unscheduled 1, 50 day. Arrows indicate areas of ARIA-E.
Fig. 4
Fig. 4
FLAIR images from patient F. (A) 80 weeks, (B) unscheduled 1, (C) unscheduled 2, (D) unscheduled 3, (E) unscheduled 4, (F) unscheduled 5. Red arrows indicate areas of ARIA-E.
Fig. 5
Fig. 5
FLAIR images from patient I. (A) 12 weeks, (B) unscheduled 1, (C) unscheduled 2, (D) unscheduled 3 (ED), (E) unscheduled 4. Red arrows indicate areas of ARIA-E.
See this image and copyright information in PMC

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