Immunogenicity, Efficacy, Safety, and Mechanism of Action of Epitope Vaccine (Lu AF20513) for Alzheimer's Disease: Prelude to a Clinical Trial
Open accessAbstract
The Alzheimer's disease (AD) process is understood to involve the accumulation of amyloid plaques and tau tangles in the brain. However, attempts at targeting the main culprits, neurotoxic Aβ peptides, have thus far proven unsuccessful for improving cognitive function. Recent clinical trials with passively administrated anti-Aβ antibodies failed to slow cognitive decline in mild to moderate AD patients, but suggest that an immunotherapeutic approach could be effective in patients with mild AD. Using an AD mouse model (Tg2576), we tested the immunogenicity (cellular and humoral immune responses) and efficacy (AD-like pathology) of clinical grade Lu AF20513 vaccine. We found that Lu AF20513 induces robust “non-self” T-cell responses and the production of anti-Aβ antibodies that reduce AD-like pathology in the brains of Tg2576 mice without inducing microglial activation and enhancing astrocytosis or cerebral amyloid angiopathy. A single immunization with Lu AF20513 induced strong humoral immunity in mice with preexisting memory T-helper cells. In addition, Lu AF20513 induced strong humoral responses in guinea pigs and monkeys. These data support the translation of Lu AF20513 to the clinical setting with the aims of: (1) inducing therapeutically potent anti-Aβ antibody responses in patients with mild AD, particularly if they have memory T-helper cells generated after immunizations with conventional tetanus toxoid vaccine, and (2) preventing pathological autoreactive T-cell responses.
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Lu AF20513 successfully removed brain amyloid deposits in the initial preclinical study.
“While Lu AF20513 was shown to successfully remove brain amyloid deposits in the initial preclinical study”
From Amyloid β-based therapy for Alzheimer’s disease: Challenges, successes and future (2023) · cites this paper as [324]
Lu AF20513 clinical trials were terminated due to a lack of efficacy.
“clinical trials were terminated due to a lack of efficacy.324”
From Amyloid β-based therapy for Alzheimer’s disease: Challenges, successes and future (2023) · cites this paper as [324]
The occurrence of encephalitis in previous studies (AN-1792) led to the development of improved anti-Aβ active immunotherapy agents, more specific to Aβ sites less probable to activate T cells, currently studied in clinical trials.
“The occurrence of encephalitis in previous studies (AN-1792)64 led to the development of improved anti-Aβ active immunotherapy agents, more specific to Aβ sites less probable to activate T cells, currently studied in clinical trials.5,6”
From Current and Future Treatments in Alzheimer Disease: An Update (2020) · cites this paper as [64]
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“In animal models, Lu AF20513 was found to induce robust "non-self" T-cell responses and induce production of anti-Aβ antibodies (53).”
Background
- Authors
- Davtyan, H., Ghochikyan, A., Petrushina, I., Hovakimyan, A., Davtyan, A., Poghosyan, A., Marleau, A. M., Movsesyan, N., Kiyatkin, A., Rasool, S., Larsen, A. K., Madsen, P. J., Wegener, K. M., Ditlevsen, D. K., Cribbs, D. H., Pedersen, L. O., & Agadjanyan, M. G.
- Affiliations
- Institute for Molecular Medicine (US)
- Thomas Jefferson University (US)
- Lundbeck (Denmark) (DK)
- University of California, Irvine (US)
- ORCID
- Venue
- The Journal of Neuroscience
- Publisher
- Society for Neuroscience
- Published
- 2013-03-13
- Volume
- 33
- Issue
- 11
- Pages
- 4923-4934
- ISSN
- 0270-6474 (ISSN-L)
- 1529-2401
- PMC
- PMC3634356
- OpenAlex
- W2069168024
- Cited by
- 112
- References
- 64
- Citations by year
- 2026: 1 · 2025: 7 · 2024: 4 · 2023: 7 · 2022: 7 · 2021: 8 · 2020: 9 · 2019: 12 · 2018: 7 · 2017: 13 · 2016: 10 · 2015: 6 · 2014: 13 · 2013: 8
- FWCI
- 8.59
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Journal of Neuroscience (publishedVersion, cc-by-nc-sa)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- Funders
- Alzheimer's Association
- H. Lundbeck A/S
- National Institutes of Health (4r01ag020241-15, AG16573, AG000096)
- National Institute on Aging (P50 AG 16573, R01 AG-020241, AG 16573, AG000096, P50AG016573, AG20241, RF1AG020241, T32AG000096)
- National Institute of Neurological Disorders and Stroke (U44NS065518, NS 50895, NS057395, NS065518, R01NS057395, R01NS050895)
- Topics
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Life Sciences › Neuroscience › Neurology › Neuroinflammation and Neurodegeneration Mechanisms
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Keywords
- Alzheimer's disease, epitope-based vaccine, amyloid-beta, anti-amyloid antibodies, immunotherapy, Tg2576 mice, immunogenicity, humoral immunity, T helper cells, microglial activation, cerebral amyloid angiopathy, vaccine safety
- MeSH terms
- Age Factors, Alzheimer Disease, Analysis of Variance, Animals, Antibodies, Anti-Idiotypic, Antibody Formation, Brain, Cells, Cultured, Disease Models, Animal, Dose-Response Relationship, Immunologic, Enzyme-Linked Immunosorbent Assay, Female, Guinea Pigs, Humans, Immunologic Memory, Macaca fascicularis, Male, Mice, Transgenic, Mutation, Neuroglia, Peptide Fragments, Protein Binding, T-Lymphocytes, Vaccination, Vaccines, Cytokines, Amyloid beta-Peptides, Amyloid beta-Protein Precursor, Epitopes, T-Lymphocyte, Epitopes, B-Lymphocyte, Surface Plasmon Resonance, Mice, Plaque, Amyloid
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
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