Evidence map›Paper›PMID 35321660›Full record

ReviewJournal of neurodevelopmental disorders2022

Conducting clinical trials in persons with Down syndrome: summary from the NIH INCLUDE Down syndrome clinical trials readiness working group.

Nicole T Baumer, Mara L Becker, George T Capone, Kathleen Egan, Juan Fortea, Benjamin L Handen, Elizabeth Head, James E Hendrix, Ruth Y Litovsky, Andre Strydom and 2 more

Open access · goldAbstract readReview
In one paragraph

Review in Journal of neurodevelopmental disorders, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
7.8field-weighted citation impact, top 2% 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

27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Use of anti-amyloid-β monoclonal antibodies in persons with Down syndrome Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Review
  6. Precision medicine for Alzheimer's disease in Down syndrome.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Article
  7. Article
  8. Article
  9. Development of Molecular Neuropathology in Down Syndrome across the Lifespan.The Journal of neuroscience : the official journal of the Society for Neuroscience · 2025
    Review
  10. Article
  11. Alzheimer's Disease Research Center Down Syndrome Cores: Experience from two sites.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Review
  12. Review
  13. Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  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

12 authors at 11 institutions in 3 countries.

Nicole T BaumerDepartment of Neurology, Division of Developmental Medicine, Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, USA.
Mara L BeckerDepartment of Pediatrics, Duke University School of Medicine, Durham, USA.
George T CaponeDepartment of Pediatrics, Kennedy Krieger Institute, The Johns Hopkins School of Medicine, Baltimore, USA.
Kathleen EganParent/Advocate, Virginia, USA.
Juan ForteaSant Pau Memory Unit, Department of Neurology, Hospital de la Santa Creu i Sant Pau, Biomedical Research Institute Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
Benjamin L HandenDepartment of Psychiatry, University of Pittsburgh, Pittsburgh, USA.
Elizabeth HeadDepartment of Pathology & Laboratory Medicine, University of California, Irvine, USA.
James E HendrixLuMind IDSC Foundation, Burlington, USA.
Ruth Y LitovskyWaisman Center, University of Wisconsin, Madison, USA.
Andre StrydomDepartment of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, London, UK.
Ignacio E TapiaDivision of Pulmonary and Sleep Medicine, Children's Hospital of Philadelphia Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA.
Michael S RafiiAlzheimer's Therapeutic Research Institute, Keck School of Medicine, University of Southern California, Los Angeles, USA. mrafii@usc.edu.ORCID 0000-0003-2640-2094
Boston University · USChildren's Hospital of Philadelphia · USDuke University · USKennedy Krieger Institute · USPatient Advocate Foundation · USSouth London and Maudsley NHS Foundation Trust · GBUniversitat Autònoma de Barcelona · ESUniversity of California, Irvine · USUniversity of Pittsburgh · USUniversity of Southern California · USUniversity of Wisconsin–Madison · US

Funding

Genetic Analysis and Manipulation Core (GAEC)P50HD105351 · NICHD · BOSTON CHILDREN'S HOSPITAL · PI Hisashi Umemori · 2021 to 2026
$9.4M
Clinical trials to prevent Alzheimer's Disease in Down SyndromeR33AG066543 · NIA · UNIVERSITY OF SOUTHERN CALIFORNIA · PI RAFII, MICHAEL S · 2022 to 2024
$6.9M
Clinical trials to prevent Alzheimer's Disease in Down SyndromeR61AG066543 · NIA · UNIVERSITY OF SOUTHERN CALIFORNIA · PI RAFII, MICHAEL S · 2019 to 2020
$5.6M
Medical Research Council MR/S011277/1NIA NIH HHS R33 AG066543NIA NIH HHS R61 AG066543NICHD NIH HHS P50 HD105351
6 · The paper itself

Abstract

The recent National Institute of Health (NIH) INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) initiative has bolstered capacity for the current increase in clinical trials involving individuals with Down syndrome (DS). This new NIH funding mechanism offers new opportunities to expand and develop novel approaches in engaging and effectively enrolling a broader representation of clinical trials participants addressing current medical issues faced by individuals with DS. To address this opportunity, the NIH assembled leading clinicians, scientists, and representatives of advocacy groups to review existing methods and to identify those areas where new approaches are needed to engage and prepare DS populations for participation in clinical trial research. This paper summarizes the results of the Clinical Trial Readiness Working Group that was part of the INCLUDE Project Workshop: Planning a Virtual Down Syndrome Cohort Across the Lifespan Workshop held virtually September 23 and 24, 2019.

Indexed as

Down SyndromeCohort StudiesHumansClinical researchClinical trialsDown syndromeIntellectual disabilityRecruitmentResearch engagement

Identifiers

PMID35321660
PMCPMC8942061
OpenAlexW4221030373

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.