{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T20:42:03Z","timestamp":1761597723228,"version":"build-2065373602"},"reference-count":41,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2016,6,21]],"date-time":"2016-06-21T00:00:00Z","timestamp":1466467200000},"content-version":"vor","delay-in-days":20,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000049","name":"National Institute on Aging","doi-asserted-by":"publisher","award":["U01\u2010AG10483"],"award-info":[{"award-number":["U01\u2010AG10483"]}],"id":[{"id":"10.13039\/100000049","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["alz-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["A&amp;D Transl Res &amp; Clin Interv"],"published-print":{"date-parts":[[2016,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>We present safety results from a study of Gammagard Liquid intravenous immunoglobulin (IGIV) in patients with probable Alzheimer's disease.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a placebo\u2010controlled double\u2010blind study. Subjects were randomized to 400\u00a0mg\/kg (n\u00a0=\u00a0127), 200\u00a0mg\/kg (n\u00a0=\u00a0135) IGIV, or to 0.25% human albumin (n\u00a0=\u00a0121) administered every 2\u00a0weeks\u00a0\u00b1\u00a07\u00a0days for 18\u00a0months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Elevated risk ratios of IGIV versus placebo included chills (3.85) in 9.5% of IGIV\u2010treated subjects (all doses), compared to 2.5% of placebo\u2010treated subjects, and rash (3.08) in 15.3% of IGIV\u2010treated subjects versus 5.0% of subjects treated with placebo. Subjects in the highest IGIV dose group had the lowest proportion of SAEs considered related to product (2 of 127 [1.6%]). Subjects treated with IGIV experienced a lower rate of respiratory and all other infections compared to placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>IGIV\u2010treated subjects did not experience higher rates of renal failure, lung injury, or thrombotic events than the placebo group. There were no unexpected safety findings. IGIV was well tolerated throughout 18\u00a0months of treatment in subjects aged 50\u201389\u00a0years.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1016\/j.trci.2016.06.003","type":"journal-article","created":{"date-parts":[[2016,6,27]],"date-time":"2016-06-27T12:29:45Z","timestamp":1467030585000},"page":"131-139","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Demonstration of safety of intravenous immunoglobulin in geriatric patients in a long\u2010term, placebo\u2010controlled study of Alzheimer's disease"],"prefix":"10.1002","volume":"2","author":[{"given":"David","family":"Gelmont","sequence":"first","affiliation":[{"name":"Clinical Development Baxalta US Inc. 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