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
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.
Authors
- Jesús Canudas
- Noelia Fandos
- Ana María Lacosta
- J. Terencio
- Jorge Loscos (ORCID: https://orcid.org/0000-0003-1435-1779)
- María Pascual‐Lucas (ORCID: https://orcid.org/0000-0002-4638-3153)
- Gerard Piñol‐Ripoll (ORCID: https://orcid.org/0000-0002-4495-2113)
- José Antonio Allué (ORCID: https://orcid.org/0000-0002-5690-3618)
- María Montañés
- Merçé Boada (ORCID: https://orcid.org/0000-0003-2617-3009)
- Leticia Sarasa
- Manuel Sarasa
- Inmaculada Monleón
- Mireia Torres
- Judith Romero
- Dermot Whyms
Institutions
- Instituto de Salud Carlos III (ES)
- Universitat Internacional de Catalunya (ES)
- Biomedical Research Networking Center on Neurodegenerative Diseases (ES)
- Hospital Universitari de Santa Maria (ES)
- The Office of Public Works (IE)
- Centro de Investigación Biomédica en Red (ES)
- Hospital Clínic de Barcelona (ES)
- Grifols (Spain) (ES)
- Fundació Clínic per a la Recerca Biomèdica (ES)
Publication Details
- Journal
- Alzheimer s & Dementia
- Published
- 2025-10-01
- DOI
- https://doi.org/10.1002/alz.70776
- Primary Topic
- Alzheimer's disease research and treatments
- Type
- article
- Field-Weighted Citation Impact
- 0.00