Evidence map›Paper›PMID 36748826›Full record

ArticleAlzheimer's & dementia : the journal of the Alzheimer's Association2023

Expectations and clinical meaningfulness of randomized controlled trials.

Ronald C Petersen, Paul S Aisen, J Scott Andrews, Alireza Atri, Brandy R Matthews, Dorene M Rentz, Eric R Siemers, Christopher J Weber, Maria C Carrillo

Open access · hybridAbstract read
In one paragraph

Article in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 1 pooled it
18.9field-weighted citation impact, top 1% 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

56 citing papers in PubMed, 1 synthesis or guideline pooled it, 85 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Eligibility for donanemab trial in a population-based study of cognitive aging.The journal of prevention of Alzheimer's disease · 2025
    Trial
  6. Trial
  7. Amyloid-beta-targeting monoclonal antibodies in early Alzheimer's disease: a cochrane review summary and appraisal for the neurological community.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
    Review
  8. Anatomy of a Setback: A Taxonomy of Clinical Trial Failures in Alzheimer's Disease and Strategic Lessons for the Future.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2026
    Review
  9. Further data to address the Alzheimer's coverage with evidence development questions.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Review
  10. Article
  11. Long-term treatment of early Alzheimer's disease with donanemab.The journal of prevention of Alzheimer's disease · 2026
    Article
  12. Article
  13. Sialylation patterns in cerebral amyloid angiopathy.Brain pathology (Zurich, Switzerland) · 2026
    Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Donanemab: Appropriate use recommendations.The journal of prevention of Alzheimer's disease · 2025
    Article
  19. Letter to the Editor.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Article
  20. Review
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

9 authors at 8 institutions in 1 country.

Ronald C PetersenDepartment of Neurology, Mayo Clinic, Rochester, Minnesota, USA.
Paul S AisenUSC Alzheimer's Therapeutic Research Institute, San Diego, California, USA.
J Scott AndrewsTakeda Pharmaceuticals, Cambridge, Massachusetts, USA.
Alireza AtriBanner Sun Health Research Institute, Banner Health, Sun City, Arizona, USA.
Brandy R MatthewsEli Lilly and Company, Indianapolis, Indiana, USA.
Dorene M RentzCenter for Alzheimer Research and Treatment, Brigham and Women's Hospital and Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Eric R SiemersSiemers Integration, LLC, Zionsville, Indiana, USA.
Christopher J WeberAlzheimer's Association, Chicago, Illinois, USA.
Maria C CarrilloAlzheimer's Association, Chicago, Illinois, USA.
Alzheimer's Association · USAutism Research Institute · USBanner Sun Health Research Institute · USEli Lilly (United States) · USMassachusetts General Hospital · USMayo Clinic · USTakeda (United States) · USZionsville Community High School · US

Funding

Research Education ComponentP30AG072980 · NIA · BANNER HEALTH · PI Nicholas Ashton · 2021 to 2026
$24.9M
NIA NIH HHS P30 AG072980
6 · The paper itself

Abstract

Alzheimer's disease (AD) clinical trials are designed and powered to detect the impact of a therapeutic intervention, and there has been considerable discussion on what constitutes a clinically meaningful change in those receiving treatment versus placebo. The pathology of AD is complex, beginning many years before clinical symptoms are detectable, with multiple potential opportunities for therapeutic engagement. Introducing treatment strategies early in the disease and assessing meaningful change over the course of an 18-month clinical trial are critical to understanding the value to an effective intervention. With new clinical trial data expected soon on emerging therapeutics from several AD studies, the Alzheimer's Association convened a work group of experts to discuss key considerations for interpreting data from cognitive and functional measures and what is considered a clinically meaningful benefit or meaningful slowing of this fatal disease. Our expectations of outcomes from therapeutic interventions in AD may need to be modified.

Indexed as

Alzheimer DiseaseCognitive DysfunctionHumansMotivationRandomized Controlled Trials as TopicAlzheimer diseaseamyloidclinical meaningfulnessclinical trialcognitioncognitive impairmentdementiaMCImild cognitive impairmenttau

Identifiers

PMID36748826
PMCPMC11156248
OpenAlexW4319332993

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.