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Cited by 35Alzheimer's disease research and treatmentsDementia and Cognitive Impairment ResearchAmyotrophic Lateral Sclerosis Research

Amyloid-beta-targeting monoclonal antibodies for people with mild cognitive impairment or mild dementia due to Alzheimer’s disease

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Nonino, Francesco, Minozzi, Silvia, Sambati, Luisa, Del Giovane, Cinzia, Baldin, Elisa, Bassi, Maria Chiara, De Santis, Claudia, Gonzalez-Lorenzo, Marien +3 more·2026·Cochrane Database of Systematic Reviews
DOI 10.1002/14651858.cd016297PMC PMC13082890
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Abstract

RATIONALE: Alzheimer's disease is a neurodegenerative disorder and the most common cause of dementia. Aggregated amyloid-beta protein deposits are implicated in its pathogenesis. Amyloid-beta-targeting monoclonal antibodies (sometimes represented as Aβ-mAbs) are potentially disease-modifying for Alzheimer's disease: through the clearance of amyloid in the brain, they may slow cognitive and functional decline. OBJECTIVES: To assess the clinical benefits and harms of amyloid-beta-targeting monoclonal antibodies aducanumab, bapineuzumab, crenezumab, donanemab, gantenerumab, lecanemab, ponezumab, remternetug, and solanezumab in people with mild cognitive impairment or mild dementia due to Alzheimer's disease. SEARCH METHODS: We searched CENTRAL, MEDLINE (PubMed), Embase, and two clinical trials registries (Clinicaltrials.gov and WHO International Clinical Trials Registry Platform), and we undertook reference checking and citation research. The most recent search date was 7 August 2025. ELIGIBILITY CRITERIA: We included randomised controlled trials (RCTs) that lasted at least 12 months and compared amyloid-beta-targeting monoclonal antibodies with placebo or no treatment in people with mild cognitive impairment or mild dementia due to Alzheimer's disease. We included both parallel-group and cluster designs. OUTCOMES: Our outcomes of critical importance were: cognitive function; dementia severity; functional ability; any amyloid-related imaging abnormality (ARIA), which includes oedema (E) and haemorrhage (H); any symptomatic ARIA E and H; symptomatic brain haemorrhage; serious adverse events; and any-cause mortality. We analysed data at 12, 18, 24, and over 24 months of treatment. RISK OF BIAS: We used the Cochrane risk of bias tool RoB 2 to assess the risk of bias in outcomes of critical importance. SYNTHESIS METHODS: We meta-analysed results for each outcome within each comparison using the inverse variance method and the random-effects model. We used GRADE to assess the certainty of evidence for each outcome as very low, low, moderate, or high. INCLUDED STUDIES: Overall, we included 17 studies with 20,342 participants. The mean age of participants in the studies ranged from 70 to 74 years. Seven studies enroled only participants with mild dementia, and one study enroled only participants with mild cognitive impairment. The remaining studies included a mixed population. The mean duration of participants' cognitive impairment ranged from 17 to 52 months. The 17 studies assessed seven different amyloid-beta-targeting monoclonal antibodies: aducanumab (n = 3), bapineuzumab (n = 4), crenezumab (n = 2), donanemab (n = 1), gantenerumab (n = 4), lecanemab (n = 1), and solanezumab (n = 2). All used placebo as a comparison. Eleven studies lasted 18 months, four lasted 24 months, and two lasted more than 24 months. All studies were funded by the pharmaceutical industry. SYNTHESIS OF RESULTS: = 81%), which prevented pooled analysis. At 18 months, amyloid-beta-targeting monoclonal antibodies do not increase serious adverse events (ARD 6 more events per 1000, 95% CI 10 fewer to 26 more; 9 studies, 11,904 participants; high certainty) or overall mortality (ARD 2 more events per 1000, 95% CI 3 fewer to 11 more; 7 studies, 9733 participants; high certainty). We judged the overall risk of bias as low for the outcomes of serious adverse events and mortality. We had some concerns about the overall risk of bias for efficacy outcomes, mainly due to the risk of functional unblinding (i.e. participants and investigators correctly guessing whether a participant is receiving the active drug or placebo because of noticeable side effects). AUTHORS' CONCLUSIONS: The effect of amyloid-beta-targeting monoclonal antibodies on cognitive function and dementia severity at 18 months in people with mild cognitive impairment or mild dementia due to Alzheimer's disease is trivial, while on functional ability, it is small at best. Amyloid-beta-targeting monoclonal antibodies increase the risk of amyloid-related imaging abnormalities. Both desirable outcomes and adverse events were inconsistently reported in the studies included in the review. Successful removal of amyloid from the brain does not seem to be associated with clinically meaningful effects in people with mild cognitive impairment or mild dementia due to Alzheimer's disease. Future research on disease-modifying treatments for Alzheimer's disease should focus on other mechanisms of action. FUNDING: This Cochrane review was funded in part by the Drug and Medical Devices Governance Area, Regione Emilia-Romagna, Bologna, Italy. The publication of this article was supported by "Ricerca Corrente" funding from the Italian Ministry of Health. REGISTRATION: Protocol (2025): PROSPERO registration number CRD420251114325.

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  • Anti-amyloid antibodies can reduce amyloid burden, but clinical benefit has remained modest and safety concerns such as amyloid-related imaging abnormalities have limited enthusiasm in some health systems.

    “Anti-amyloid antibodies can reduce amyloid burden, but clinical benefit has remained modest and safety concerns such as amyloid-related imaging abnormalities have limited enthusiasm in some health systems.”

    From Lymphoid-like Suppressive Microglia in Alzheimer’s Disease: A New Neuroimmune Regulatory Axis? (2026) · cites this paper as [54]

    The Background reports reduced brain amyloid, and the Authors’ conclusions describe clinical effects as small or absent and ARIA risk as high. The paper also discusses healthcare-system burdens and debate over net benefit, but it does not establish that safety concerns have limited enthusiasm in particular health systems. (LLM, conf=0.82)

    Experimental — accuracy not yet measured

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Authors
Nonino, F., Minozzi, S., Sambati, L., Del Giovane, C., Baldin, E., Bassi, M. C., De Santis, C., Gonzalez-Lorenzo, M., Vignatelli, L., Filippini, G., & Richard, E.
Affiliations
  • Istituto delle Scienze Neurologiche di Bologna (IT)
  • Mario Negri Institute for Pharmacological Research (IT)
  • Department of Medical and Surgical Sciences for Children and Adults; University of Modena and Reggio Emilia; Modena Italy
  • Medical Library; Azienda USL - IRCCS di Reggio Emilia; Reggio Emilia Italy
  • Unit of Epidemiology and Statistics; IRCCS Istituto delle Scienze Neurologiche di Bologna; Bologna Italy
  • Laboratory of Methodology of Systematic Reviews and Guidelines production, Department of Experimental Oncology; Istituto di Ricerche Farmacologiche Mario Negri IRCCS; Milan Italy
  • Independent Researcher; Milan Italy
  • Radboud University Medical Center (NL)
Corresponding author
Nonino, Francesco
ORCID
Venue
Cochrane Database of Systematic Reviews
Publisher
Wiley
Published
2026-04-16
Volume
2026
Issue
4
Pages
CD016297-CD016297
ISSN
  • 1361-6137 (ISSN-L)
  • 1465-1858
DOI
10.1002/14651858.cd016297
PMC
PMC13082890
OpenAlex
W7154509695
Cited by
35
References
110
Citations by year
2026: 35
FWCI
36.61
Type
journal article
Language
en
Open access
Licence
cc-by-nc
Locations
  • Cochrane Database of Systematic Reviews (publishedVersion)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • Radboud Repository (Radboud University) (submittedVersion)
  • IRIS UNIMORE (University of Modena and Reggio Emilia) (submittedVersion, cc-by)
  • Open Access CRIS of the University of Bern
Funders
  • Ministero della Salute
  • Regione Emilia-Romagna
Topics
  • Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
  • Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
  • Health Sciences › Medicine › Neurology › Amyotrophic Lateral Sclerosis Research
Keywords
Alzheimer's disease, mild cognitive impairment, mild dementia, aducanumab, bapineuzumab, crenezumab, donanemab, gantenerumab, lecanemab, solanezumab, amyloid-related imaging abnormalities, amyloid plaques, cognitive decline
MeSH terms
Aged, Alzheimer Disease, Antibodies, Monoclonal, Dementia, Humans, Randomized Controlled Trials as Topic, Amyloid beta-Peptides, Cognitive Dysfunction, Antibodies, Monoclonal, Humanized

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