{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T05:13:07Z","timestamp":1792818787669,"version":"4.5.0"},"reference-count":50,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2025,10,7]],"date-time":"2025-10-07T00:00:00Z","timestamp":1759795200000},"content-version":"vor","delay-in-days":6,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["alz-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Alzheimer's &amp;amp; Dementia"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>INTRODUCTION<\/jats:title>\n                    <jats:p>ABvac40 is an investigational active immunotherapy (vaccine) targeting A\u03b240. This study assessed the safety and immunogenicity of ABvac40 in patients with amnestic mild cognitive impairment or very mild Alzheimer's disease.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>\n                      AB1601 was a multicenter, randomized, double\u2010blind, placebo\u2010controlled phase 2 study. Patients (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0124) received five monthly injections plus a 10\u2010month booster of ABvac40 or placebo, with 18\u201324 months of follow\u2010up. Primary endpoints included safety, tolerability, and immunogenicity. Secondary endpoints assessed immune response, neuropsychological changes, and disease biomarkers.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>Treatment\u2010emergent adverse events (TEAEs) and serious TEAEs were comparable between ABvac40 (90.6% and 26.6%) and placebo (93.3% and 26.7%). Amyloid\u2010related imaging abnormalities\u2010hemorrhage (ARIA\u2010H) were similar (12.5% ABvac40; 15.0% placebo), with no ARIA\u2010edema (ARIA\u2010E) or meningoencephalomyelitis. ABvac40 induced a specific, sustained immune response in plasma, with detectable antibodies in CSF.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>DISCUSSION<\/jats:title>\n                    <jats:p>These findings support further investigation of ABvac40 as a potential disease\u2010modifying therapy.<\/jats:p>\n                    <jats:p>Clinical Trial Registration Number: NCT03461276 (ClinicalTrials.gov)<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Highlights<\/jats:title>\n                    <jats:p>\n                      <jats:list list-type=\"bullet\">\n                        <jats:list-item>\n                          <jats:p>ABvac40 was safe and well\u2010tolerated in early\u2010stage Alzheimer's disease patients.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>No amyloid\u2010related imaging abnormalities\u2010edema (ARIA\u2010E) or encephalitis observed; ARIA\u2010hemorrhage (ARIA\u2010H) rates were similar across groups.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>Specific, sustained immune response to ABvac40 in plasma, with cerebrospinal fluid (CSF) antibody penetration.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>Cognitive scales and magnetic resonance imaging (MRI) volumetric data favored ABvac40 over placebo.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>Results support further development of ABvac40 as a disease\u2010modifying therapy.<\/jats:p>\n                        <\/jats:list-item>\n                      <\/jats:list>\n                    <\/jats:p>\n                  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