Evidence map›Paper›PMID 37830926›Full record

ArticleAnnals of neurology2024

Eligibility Rates among Racially and Ethnically Diverse US Participants in Phase 2 and Phase 3 Placebo-Controlled, Double-Blind, Randomized Trials of Lecanemab and Elenbecestat in Early Alzheimer Disease.

Joshua D Grill, Charlene Flournoy, Shobha Dhadda, Karin Ernstrom, Reisa Sperling, Doris Molina-Henry, Kate Tranotti, Russell Harris, Michio Kanekiyo, Michelle Gee and 4 more

Open access · bronzeAbstract read
In one paragraph

Article in Annals of neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 pooled it
6.2field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
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  7. Article
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  9. Review
  10. Article
  11. Amyloid PET and clinical management in a diverse, cognitively impaired population: The New IDEAS Study.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Observational
  12. Review
  13. Article
  14. Article
  15. Distinct medical and substance use histories associate with cognitive decline in Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Article
  16. Article
  17. Article
  18. Observational
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 5 institutions in 2 countries.

Joshua D GrillInstitute for Memory Impairments and Neurological Disorders, Departments of Psychiatry and Human Behavior and Neurobiology and Behavior, University of California, Irvine, Irvine, CA, USA.ORCID 0000-0002-4215-7589
Charlene FlournoyAlzheimer's Therapeutic Research Institute, University of Southern California, San Diego, CA, USA.
Shobha DhaddaEisai Inc, Nutley, NJ, USA.
Karin ErnstromAlzheimer's Therapeutic Research Institute, University of Southern California, San Diego, CA, USA.
Reisa SperlingBrigham and Women's Hospital, Massachusetts General Hospital, Boston, MA, USA.
Doris Molina-HenryAlzheimer's Therapeutic Research Institute, University of Southern California, San Diego, CA, USA.
Kate TranottiEisai Inc, Nutley, NJ, USA.
Russell HarrisEisai Inc, Nutley, NJ, USA.
Michio KanekiyoEisai Inc, Nutley, NJ, USA.
Michelle GeeEisai Co Ltd, Hatfield, UK.
Michael IrizarryEisai Inc, Nutley, NJ, USA.
Lynn KramerEisai Inc, Nutley, NJ, USA.
Paul AisenAlzheimer's Therapeutic Research Institute, University of Southern California, San Diego, CA, USA.
Rema RamanAlzheimer's Therapeutic Research Institute, University of Southern California, San Diego, CA, USA.
Eisai (United States) · USUniversity of Southern California · USBrigham and Women's Hospital · USEisai (United Kingdom) · GBUniversity of California, Irvine · US

Funding

The Alzheimer's Clinical Trial Consortium - Down Syndrome Network (ACTC- DSN)U24AG057437 · NIA · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Paul S. Aisen, RONALD C PETERSEN · 2018 to 2026
$198.4M
The Alzheimer's Disease Research Center at the University of California, IrvineP30AG066519 · NIA · UNIVERSITY OF CALIFORNIA-IRVINE · PI Crystal M. Glover · 2020 to 2026
$27.9M
NIA NIH HHS P30 AG066519NIA NIH HHS U24 AG057437
6 · The paper itself

Abstract

objectiveMany factors contribute to inadequate diversity in Alzheimer disease (AD) clinical trials. We evaluated eligibility rates among racial and ethnic groups at US sites in large global multisite trials in early AD.

methodsUsing screening data from 4 randomized, double-blind, placebo-controlled clinical trials in early AD, we assessed rates of eligibility among racial and ethnic groups controlling for other demographic covariates. Each trial incorporated positron emission tomography and/or cerebrospinal fluid to evaluate brain amyloid pathology, as well as typical eligibility criteria used in early AD trials.

resultsAcross the trials, 10,804 US participants were screened: 193 (2%) were of Hispanic ethnicity and Black race, 2,624 (25%) were of Hispanic ethnicity and White race, 118 (1%) were of non-Hispanic ethnicity (NH) and Asian race, 696 (7%) were of NH ethnicity and Black race, and 7,017 (65%) were of NH ethnicity and White race. Data from 156 participants who did not fit into these categories were excluded. Accounting for age, sex, and trial and using NH White participants as a reference group, we observed higher probabilities of ineligibility for amyloid biomarker criteria among Hispanic Black (odds ratio [OR] = 3.20, 95% confidence interval [CI] = 2.11-4.88), Hispanic White (OR = 4.15, 95% CI = 3.58-4.83), NH Asian (OR = 2.35, 95% CI = 1.23-4.55), and NH Black (OR = 3.75, 95% CI = 2.80-5.06) participants.

interpretationDifferential eligibility may contribute to underrepresentation of some minoritized racial and ethnic groups in early AD trials. Amyloid biomarker eligibility is a requirement to confirm the diagnosis of AD and for treatment with amyloid-lowering drugs and differed among racial and ethnic groups. ANN NEUROL 2024;95:288-298.

Indexed as

Alzheimer DiseaseAntibodies, Monoclonal, HumanizedPatient SelectionAsianBiomarkersBlack or African AmericanClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicEthnicityHispanic or LatinoHumansRacial GroupsRandomized Controlled Trials as TopicWhiteAntibodies, Monoclonal, HumanizedBiomarkerslecanemab

Identifiers

PMID37830926
PMCPMC11733864
OpenAlexW4387597538

What OpenQuestion holds

Textmetadata
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Read underepoch 390

Registered trials

None linked

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.