2026-04-17T07:46:15Zhttps://recercat.cat/oai/request
oai:recercat.cat:10459.1/4690062025-11-17T19:34:22Zcom_2072_3622col_2072_479130
RECERCAT author Pascual Lucas, María author Lacosta, Ana María author Montañés, María author Canudas, Jesús author Loscos, Jorge author Monleón, Inmaculada author Allué, José Antonio author Sarasa, Leticia author Fandos, Noelia author Romero, Judith author Sarasa, Manuel author Torres, Mireia author Whyms, Dermot author Terencio, Jose author Piñol Ripoll, Gerard author Boada, Mercè 2025-11-17T19:34:22Z 2025-11-17T19:34:22Z 2025-09 http://hdl.handle.net/10459.1/469006 Introduction: ABvac40 is an investigational active immunotherapy (vaccine) targeting Aβ40. This study assessed the safety and immunogenicity of ABvac40 in patients with amnestic mild cognitive impairment or very mild Alzheimer's disease. Methods: AB1601 was a multicenter, randomized, double-blind, placebo-controlled phase 2 study. Patients (n = 124) received five monthly injections plus a 10-month booster of ABvac40 or placebo, with 18-24 months of follow-up. Primary endpoints included safety, tolerability, and immunogenicity. Secondary endpoints assessed immune response, neuropsychological changes, and disease biomarkers. Results: Treatment-emergent adverse events (TEAEs) and serious TEAEs were comparable between ABvac40 (90.6% and 26.6%) and placebo (93.3% and 26.7%). Amyloid-related imaging abnormalities-hemorrhage (ARIA-H) were similar (12.5% ABvac40; 15.0% placebo), with no ARIA-edema (ARIA-E) or meningoencephalomyelitis. ABvac40 induced a specific, sustained immune response in plasma, with detectable antibodies in CSF. Discussion: These findings support further investigation of ABvac40 as a potential disease-modifying therapy. Clinical trial registration number: NCT03461276 (ClinicalTrials.gov) HIGHLIGHTS: ABvac40 was safe and well-tolerated in early-stage Alzheimer's disease patients. No amyloid-related imaging abnormalities-edema (ARIA-E) or encephalitis observed; ARIA-hemorrhage (ARIA-H) rates were similar across groups. Specific, sustained immune response to ABvac40 in plasma, with cerebrospinal fluid (CSF) antibody penetration. Cognitive scales and magnetic resonance imaging (MRI) volumetric data favored ABvac40 over placebo. Results support further development of ABvac40 as a disease-modifying therapy. cc-by-nc-nd, (c) María Pascual Lucas et al., 2025 Attribution-NonCommercial-NoDerivatives 4.0 International info:eu-repo/semantics/openAccess http://creativecommons.org/licenses/by-nc-nd/4.0/ ABvac40 Alzheimer's disease Aβ40 Active immunotherapy Clinical trial Safety, tolerability, immunogenicity, and efficacy of ABvac40 active immunotherapy against Aβ40 in patients with mild cognitive impairment or very mild Alzheimer's disease: A randomized, double-blind, placebo-controlled phase 2 study info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion