Evidence map›Paper›PMID 38165296›Full record

ArticleNeurology2024

Genome-Wide Association Studies of ARIA From the Aducanumab Phase 3 ENGAGE and EMERGE Studies.

Stephanie J Loomis, Ryan Miller, Carmen Castrillo-Viguera, Kimberly Umans, Wenting Cheng, John O'Gorman, Richard Hughes, Samantha Budd Haeberlein, Christopher D Whelan

2 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
5.4field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02477800 phase3terminatednot on this map

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease

TypeinterventionalSponsorBiogenRan2015 to 2019Enrolled1,653ConditionsAlzheimer's DiseaseArmsAducanumab (BIIB037), Placebo
NCT02484547 phase3terminatednot on this map

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease

TypeinterventionalSponsorBiogenRan2015 to 2019Enrolled1,643ConditionsAlzheimer's DiseaseArmsAducanumab (BIIB037), Placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Incidence, severity, and associated risk factors for amyloid-related imaging abnormalities in anti-amyloid monoclonal antibody therapy for early Alzheimer's disease: a systematic review and meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
    Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Article
  9. PreoperativeFrontiers in bioinformatics · 2026
    Review
  10. Article
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Stephanie J LoomisFrom the Biogen, Cambridge, MA.ORCID 0000-0002-7478-1538
Ryan MillerFrom the Biogen, Cambridge, MA.ORCID 0009-0001-4268-0214
Carmen Castrillo-VigueraFrom the Biogen, Cambridge, MA.
Kimberly UmansFrom the Biogen, Cambridge, MA.ORCID 0009-0006-2717-8265
Wenting ChengFrom the Biogen, Cambridge, MA.ORCID 0000-0003-2199-1467
John O'GormanFrom the Biogen, Cambridge, MA.ORCID 0000-0001-6549-4038
Richard HughesFrom the Biogen, Cambridge, MA.ORCID 0000-0001-5532-406X
Samantha Budd HaeberleinFrom the Biogen, Cambridge, MA.ORCID 0000-0002-4824-646X
Christopher D WhelanFrom the Biogen, Cambridge, MA.
Biogen (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesAmyloid-related imaging abnormalities (ARIA) were the most common adverse events reported in the phase 3 ENGAGE and EMERGE trials of aducanumab, an anti-amyloid monoclonal antibody.

methodsWe performed genome-wide association studies (GWAS) of ARIA in participants in the ENGAGE and EMERGE trials. Participants had mild cognitive impairment due to Alzheimer disease or mild Alzheimer disease dementia and were amyloid-positive on PET scans. All participants underwent regular MRI monitoring to detect and diagnose ARIA.

resultsOf the 3,285 participants in the intent-to-treat population, this analysis included 1,691 with genotyping array data who received at least one dose of aducanumab with at least one post-baseline MRI. All participants in the study cohort were of European ancestry; 51% were female. The mean age was 70.3 years. 31% had ARIA-E, 19% had ARIA-H microhemorrhage, and 14% had ARIA-H superficial siderosis. We identified one genome-wide significant ( DISCUSSION: We identified a strong, genome-wide significant association between TRIAL REGISTRATION INFORMATION: Both trials (ENGAGE [221AD301]: NCT02477800 and EMERGE [221AD302]: NCT02484547) were registered in June 2015 at clinicaltrials.gov and enrolled patients from August 2015 to July 2018.

Indexed as

Alzheimer DiseaseSiderosisAgedAmyloidogenic ProteinsAntibodies, Monoclonal, HumanizedApolipoprotein E4FemaleGenome-Wide Association StudyHumansMaleaducanumabAmyloidogenic ProteinsAntibodies, Monoclonal, HumanizedApolipoprotein E4

Identifiers

PMID38165296
PMCPMC11097767
OpenAlexW4390381496

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.