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81/100

✓ Peer-reviewed alzhub usefulness score 81 out of 100. Treatments

Topic: Amyloid, tau and blood-test diagnosis

Background Lecanemab (BAN2401), an IgG1 monoclonal antibody, preferentially targets soluble aggregated amyloid beta (Aβ), with activity across oligomers, protofibrils, and insoluble fibrils. BAN2401-G000-201, a randomized double-blind clinical trial, utilized a Bayesian design with response-adaptive randomization to assess 3 doses across 2 regimens of lecanemab versus placebo in early Alzheimer's disease, mild cognitive impairment due to Alzheimer's disease (AD) and mild AD dementia. Methods BAN2401-G000-201 aimed to establish the effective dose 90% (ED90), defined as the simplest dose that achieves ≥90% of the maximum treatment effect. The primary endpoint was Bayesian analysis of 12-month clinical change on the Alzheimer's Disease Composite Score (ADCOMS) for the ED90 dose, which required an 80% probability of ≥25% clinical reduction in decline versus placebo. Key secondary endpoints included 18-month Bayesian and frequentist analyses of brain amyloid reduction using positron emission tomography; clinical decline on ADCOMS, Clinical Dementia Rating-Sum-of-Boxes (CDR-SB), and Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14); changes in CSF core biomarkers; and total hippocampal volume (HV) using volumetric magnetic resonance imaging. Results A total of 854 randomized subjects were treated (lecanemab, 609; placebo, 245). At 12 months, the 10-mg/kg biweekly ED90 dose showed a 64% probability to be better than placebo by 25% on ADCOMS, which missed the 80% threshold for the primary outcome. At 18 months, 10-mg/kg biweekly lecanemab reduced brain amyloid (-0.306 SUVr units) while showing a drug-placebo difference in favor of active treatment by 27% and 30% on ADCOMS, 56% and 47% on ADAS-Cog14, and 33% and 26% on CDR-SB versus placebo according to Bayesian and frequentist analyses, respectively. CSF biomarkers were supportive of a treatment effect. Lecanemab was well-tolerated with 9.9% incidence of amyloid-related imaging abnormalities-edema/effusion at 10 mg/kg biweekly. Conclusions BAN2401-G000-201 did not meet the 12-month primary endpoint. However, prespecified 18-month Bayesian and frequentist analyses demonstrated reduction in brain amyloid accompanied by a consistent reduction of clinical decline across several clinical and biomarker endpoints. A phase 3 study (Clarity AD) in early Alzheimer's disease is underway. Trial registration Clinical Trials.gov NCT01767311 .

Cite this study APA, Vancouver, BibTeX · download .bib or .ris

APA 7th

Swanson, C. J., Zhang, Y., Dhadda, S., Wang, J., Kaplow, J., Lai, R. Y. K., et al. (2021). A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer's disease with lecanemab, an anti-Aβ protofibril antibody. Alzheimer's research & therapy. https://doi.org/10.1186/s13195-021-00813-8

Vancouver

Swanson CJ, Zhang Y, Dhadda S, Wang J, Kaplow J, Lai RYK, et al. A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer's disease with lecanemab, an anti-Aβ protofibril antibody. Alzheimer's research & therapy. 2021. doi:10.1186/s13195-021-00813-8. PMID: 33865446.

BibTeX

@article{swanson2021-33865446,
  author  = {Swanson, C. J. and Zhang, Y. and Dhadda, S. and Wang, J. and Kaplow, J. and Lai, R. Y. K. and Lannfelt, L. and Bradley, H. and others},
  title   = {{A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer's disease with lecanemab, an anti-Aβ protofibril antibody}},
  journal = {Alzheimer's research \& therapy},
  year    = {2021},
  doi     = {10.1186/s13195-021-00813-8},
  pmid    = {33865446},
  url     = {https://doi.org/10.1186/s13195-021-00813-8}
}

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Key findings

BAN2401-G000-201, a randomized double-blind clinical trial, utilized a Bayesian design with response-adaptive randomization to assess 3 doses across 2 regimens of lecanemab versus placebo in early Alzheimer's disease, mild cognitive impairment due to Alzheimer's disease (AD) and mild AD dementia.
The primary endpoint was Bayesian analysis of 12-month clinical change on the Alzheimer's Disease Composite Score (ADCOMS) for the ED90 dose, which required an 80% probability of ≥25% clinical reduction in decline versus placebo.
Results A total of 854 randomized subjects were treated (lecanemab, 609; placebo, 245).
At 18 months, 10-mg/kg biweekly lecanemab reduced brain amyloid (-0.306 SUVr units) while showing a drug-placebo difference in favor of active treatment by 27% and 30% on ADCOMS, 56% and 47% on ADAS-Cog14, and 33% and 26% on CDR-SB versus placebo according to Bayesian and frequentist analyses, respectively.
However, prespecified 18-month Bayesian and frequentist analyses demonstrated reduction in brain amyloid accompanied by a consistent reduction of clinical decline across several clinical and biomarker endpoints.

Why it matters

This phase 2b trial tested lecanemab, an antibody targeting soluble aggregated amyloid beta, in people with early Alzheimer's disease, mild cognitive impairment due to Alzheimer's disease, and mild Alzheimer's disease dementia, using a Bayesian design to find the effective dose. It is a proof-of-concept trial and does not establish that lecanemab cures or prevents Alzheimer's disease.

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Study details

Study designclinical trial
Participants18
Effect size9.9%
Evidence strengthHigh

How this study scored 81/100

Published in a peer-reviewed journal, and it is a randomised controlled trial.

Component	Points	Why
Journal tier	7 / 10	Tier 3 — peer-reviewed journal (Alzheimer's research & therapy)
Journal's citation record	1 / 4	Alzheimer s Research & Therapy: journal h-index 146 (OpenAlex, 2026-10-29)
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	3 / 5	2021 — within 6 year(s) of the newest study here
Sample size	1 / 4	18 participants
Effect reported	2 / 3	Effect reported as a number, without an interval or test
Studied in people	3 / 3	Studied in people (participant count stated)
Randomised / blinded	2 / 2	Randomised and blinded or placebo-controlled (as stated in the record)
Times cited	6 / 7	Cited 837 times (OpenAlex, 2026-10-10)
Citations per year	5 / 5	119.6 citations a year over 7 year(s) since 2021
Impact for its field and year	6 / 6	Cited 74.0× the average for papers of its field and year (OpenAlex FWCI)
Cited by studies here	4 / 6	Cited by 65 other studies in this library
Still being cited	4 / 4	Cited 464 times in 2024–2026 (2026 still in progress; OpenAlex)
Senior author's track record	4 / 4	Last-listed author Jeffrey L. Cummings: h-index 175 (OpenAlex, whole career)
Institution's track record	1 / 3	Uppsala University: institution h-index 1,114 (OpenAlex)
Multi-centre collaboration	2 / 3	OpenAlex lists 5 institution(s) in 3 countries
Indexed in PubMed	2 / 2	Indexed in PubMed (PMID 33865446)
Free to read	2 / 2	Free to read
Total	81 / 100	—

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