Authors
María Pascual-Lucas, Ana María Lacosta, María Montañés, Jesús Canudas, Jorge Loscos, Inmaculada Monleón, José Antonio Allué, Leticia Sarasa, Noelia Fandos, Judith Romero, Manuel Sarasa, Mireia Torres, Dermot Whyms, Jose Terencio, Gerard Piñol-Ripoll, Mercè Boada
Published in
Alzheimer's & dementia : the journal of the Alzheimer's Association. Volume 22. Issue 8. Pages e71746.
Abstract
ABvac40 is an active immunotherapy targeting Aβ40, the main component of cerebrovascular deposition in Alzheimer's disease (AD). A 24-month randomized, placebo-controlled phase 2 study (Part A) showed favorable safety and robust immunogenicity, with exploratory signals of clinical efficacy. Here, we report results from Part B, an 18-month extension evaluating long-term safety and immunological memory.
Participants treated with ABvac40 in Part A received placebo plus a delayed booster, whereas previous placebo participants received ABvac40. Exploratory endpoints included safety, tolerability, and immunogenicity.
Seventy-seven participants entered Part B. Treatment-emergent adverse events (TEAEs) occurred in 75.0% of participants in placebo + booster group and 81.1% in ABvac40 group; serious TEAEs were 5.0% and 16.2%, respectively. No ARIA-E or meningoencephalomyelitis were observed, with one ARIA-H event. ABvac40 induced robust antibody responses following delayed booster, with detectable anti-Aβ40 antibodies in CSF.
ABvac40 showed favorable long-term safety and durable immunogenicity, supporting further clinical development.
ClinicalTrials.gov: NCT03461276, registered March 2, 2018. EudraCT: 2016-004352-30, registered March 10, 2017.
PMID:
42590850
Bibliographic data and abstract were imported from PubMed on 13 Aug 2026.
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