Evidence map›Paper›PMID 41328259›Full record

ArticleAlzheimer's & dementia (New York, N. Y.)

Assessing safety and efficacy in subpopulations in Alzheimer's disease clinical trials: contextualizing representativeness.

Guogen Shan, Jeffrey Cummings

Abstract read
In one paragraph

Article in Alzheimer's & dementia (New York, N. Y.). The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Article
  2. 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

2 authors.

Guogen ShanDepartment of Biostatistics University of Florida Gainesville Florida USA.
Jeffrey CummingsChambers-Grundy Center for Transformative Neuroscience Department of Brain Health Kirk Kerkorian School of Medicine University of Nevada Las Vegas (UNLV) Las Vegas Nevada USA.

Funding

Renewal of Centers of Biomedical Research Excellence (COBRE) (Phase 2) CNTN - ResubmissionP20GM109025 · NIGMS · CLEVELAND CLINIC FOUNDATION · PI JESSICA KIRKLAND CALDWELL · 2015 to 2026
$22.8M
Risk and Resilience, Clinical presentation, and Biomarker Profiles of Chronic Traumatic Encephalopathy and Related Dementias: The DIAGNOSE CTE Research Project IIR01NS139383 · NINDS · BOSTON UNIVERSITY MEDICAL CAMPUS · PI Michael Alosco, Nicholas Ashton · 2024 to 2026
$9.3M
Alzheimer's Clinical Trial InnOvatioN (ACTION) InitiativeR35AG071476 · NIA · UNIVERSITY OF NEVADA LAS VEGAS · PI CUMMINGS, JEFFREY L. · 2021 to 2025
$2.9M
Alzheimer's Disease: New Trial Designs for Emerging ChallengesR01AG070849 · NIA · UNIVERSITY OF NEVADA LAS VEGAS · PI SHAN, GUOGEN · 2021 to 2025
$1.5M
Application of deep learning and novel survival models to predict MCI-to-AD dementia progressionR03AG083207 · NIA · UNIVERSITY OF FLORIDA · PI SHAN, GUOGEN · 2023 to 2024
$164k
NIA NIH HHS R01 AG070849NIA NIH HHS R03 AG083207NIA NIH HHS R35 AG071476NIGMS NIH HHS P20 GM109025NINDS NIH HHS R01 NS139383
6 · The paper itself

Abstract

Efficacy outcomes in clinical trials are based on well-powered analyes of the entire participating population. Trial populations will comprise many types of demographic and biological subgroups, including individuals of different sexes, groups of older and younger individuals, participants with or without the apolipoprotein E ε4 ( Highlights: Clinical trials are sized to allow well-powered conclusions based on analysis of the entire participating population.Trial populations geared to be representative of the subgroups of the older population with AD are underpowered to allow drawing confident conclusions about efficacy or safety in subgroups.Strategies such as non-inferiority analysis combined with transparent reporting of the analytic framework may facilitate understanding treatment efficacy and safety in subgroups.

Indexed as

Alzheimer's diseaseclinical trialsdiversityinteraction analysisnon‐inferiorityrepresentativenessstatistical analysis

Identifiers

PMID41328259
PMCPMC12664824

What Socratic 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 Socratic graph.