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Long-term safety and immunogenicity of ABvac40 active immunotherapy in mild cognitive impairment and very mild Alzheimer's disease: Results from AB1601 phase 2 extension study
Pascual-Lucas M, Lacosta AM, Montañés M, Canudas J, Loscos J, Monleón I, Allué JA, Sarasa L et al.. Alzheimer's & dementia : the journal of the Alzheimer's Association, 2026-08-01
Topic: Amyloid, tau and blood-test diagnosis
Introduction 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. Methods 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. Results 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. Discussion ABvac40 showed favorable long-term safety and durable immunogenicity, supporting further clinical development. Trial registration ClinicalTrials.gov: NCT03461276, registered March 2, 2018. EudraCT: 2016-004352-30, registered March 10, 2017.
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APA 7th
Pascual-Lucas, M., Lacosta, A. M., Montañés, M., Canudas, J., Loscos, J., Monleón, I., et al. (2026). Long-term safety and immunogenicity of ABvac40 active immunotherapy in mild cognitive impairment and very mild Alzheimer's disease: Results from AB1601 phase 2 extension study. Alzheimer's & dementia : the journal of the Alzheimer's Association. https://doi.org/10.1002/alz.71746
Vancouver
Pascual-Lucas M, Lacosta AM, Montañés M, Canudas J, Loscos J, Monleón I, et al. Long-term safety and immunogenicity of ABvac40 active immunotherapy in mild cognitive impairment and very mild Alzheimer's disease: Results from AB1601 phase 2 extension study. Alzheimer's & dementia : the journal of the Alzheimer's Association. 2026. doi:10.1002/alz.71746. PMID: 42590850.
BibTeX
@article{pascuallucas2026-42590850,
author = {Pascual-Lucas, M. and Lacosta, A. M. and Montañés, M. and Canudas, J. and Loscos, J. and Monleón, I. and Allué, J. A. and Sarasa, L. and others},
title = {{Long-term safety and immunogenicity of ABvac40 active immunotherapy in mild cognitive impairment and very mild Alzheimer's disease: Results from AB1601 phase 2 extension study}},
journal = {Alzheimer's \& dementia : the journal of the Alzheimer's Association},
year = {2026},
doi = {10.1002/alz.71746},
pmid = {42590850},
url = {https://doi.org/10.1002/alz.71746}
}
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Key findings
- Here, we report results from Part B, an 18-month extension evaluating long-term safety and immunological memory.
- Results Seventy-seven participants entered Part B.
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Study details
- Study designclinical trial
- Effect size75.0%; 81.1%; 5.0%
- Evidence strengthHigh
How this study scored 87/100
Published in a leading specialty journal, and it is a randomised controlled trial. Scored zero for sample size because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record and institution's track record, so those were left out: it earned 53 of the 61 points we could judge it on, which is 87 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Alzheimer's & dementia : the journal of the Alzheimer's Association) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 11 / 12 | A randomised controlled trial (from PubMed type “Randomized Controlled Trial”) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 5 / 5 | 2026 — within 1 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 3 / 3 | Studied in people (pubmed indexes it as a clinical or observational study) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | 2 / 3 | PubMed indexes it as a multicentre study |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 42590850) |
| Free to read | 2 / 2 | Free to read |
| Points | 53 / 61 | Scored on 12 of 20 parts. We have no data for the rest, so they are left out: 53 of the 61 points we could judge it on is 87 out of 100. |
| Total | 87 / 100 | — |
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