Evidence map›Paper›PMID 35841252›Full record

ReviewThe journal of prevention of Alzheimer's disease2022

Clinical Trial Endpoints and Their Clinical Meaningfulness in Early Stages of Alzheimer's Disease.

S Cohen, J Cummings, S Knox, M Potashman, J Harrison

Registry-linked trialOpen access · diamondAbstract readReview
In one paragraph

Review in The journal of prevention of Alzheimer's disease, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06868030 (Efficacy and Safety of Conventional Symptomatic Drugs Combined with Lencanizumab in the Treatment of Early Alzheimer's Disease), which is not on this map. Cited by 44 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 4 pooled it
8.1field-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.

NCT06868030 not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Efficacy and Safety of Conventional Symptomatic Drugs Combined with Lencanizumab in the Treatment of Early Alzheimer's Disease: a Multicenter, Prospective, Observational Study

TypeobservationalSponsorFirst Hospital of China Medical UniversityRan2025 to 2026Enrolled120ConditionsAlzheimer's Disease, MCI-AD, Early Stage Alzheimer&#39, s Disease
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 4 syntheses or guidelines pooled it, 59 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  4. Pooled it
  5. Trial
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  10. 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
  11. Review
  12. Article
  13. Cognitive Trajectories from Preclinical Alzheimer's Disease to Dementia.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
  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

5 authors at 5 institutions in 4 countries.

S CohenSharon Cohen, MD. Toronto Memory Program, Toronto, ON, Canada. Phone (+1) 416-386-9761; Fax (+1) 416-386-0458; Email: cohen@memorydisorders.ca.
J Cummings
S Knox
M Potashman
J Harrison
Advisory Board Company (United States) · USBiogen (Switzerland) · CHBiogen (United States) · USCambridge Cognition (United Kingdom) · GBUniversity of Nevada, Las Vegas · US

Funding

Trial-Ready Cohort for Preclinical/Prodromal Alzheimer's DiseaseR01AG053798 · NIA · UNIVERSITY OF SOUTHERN CALIFORNIA · PI AISEN, PAUL S., CUMMINGS, JEFFREY L. · 2017 to 2022
$39.4M
Research Education ComponentP30AG072980 · NIA · BANNER HEALTH · PI Nicholas Ashton · 2021 to 2026
$24.9M
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
Chronic Traumatic Encephalopathy: Detection, Diagnosis, Course, and Risk FactorsU01NS093334 · NINDS · BOSTON UNIVERSITY MEDICAL CAMPUS · PI CUMMINGS, JEFFREY L., REIMAN, ERIC MICHAEL · 2016 to 2022
$17.0M
NVEDARC Clinical CoreP20AG068053 · NIA · CLEVELAND CLINIC FOUNDATION · PI FOX, ROBERT J. · 2020 to 2022
$3.3M
Alzheimer's Clinical Trial InnOvatioN (ACTION) InitiativeR35AG071476 · NIA · UNIVERSITY OF NEVADA LAS VEGAS · PI CUMMINGS, JEFFREY L. · 2021 to 2025
$2.9M
NIA NIH HHS P20 AG068053NIA NIH HHS P30 AG072980NIA NIH HHS R01 AG053798NIA NIH HHS R35 AG071476NIGMS NIH HHS P20 GM109025NINDS NIH HHS U01 NS093334
6 · The paper itself

Abstract

As the focus of Alzheimer's disease (AD) therapeutic development shifts to the early stages of the disease, the clinical endpoints used in drug trials, and how these might translate into clinical practice, are of increasing importance. The clinical meaningfulness of trial outcome measures is often unclear, with a lack of conclusive evidence as to how these measures correlate to changes in disease progression and treatment response. Clarifying this would benefit all, including patients, care partners, primary care providers, regulators, and payers, and would enhance our understanding of the relationship between clinical trial endpoints and assessments used in everyday practice. At present, there is a wide range of assessment tools used in clinical trials for AD and substantial variability in measures selected as endpoints across these trials. The aim of this review is to summarize the most commonly used assessment tools for early stages of AD, describe their use in clinical trials and clinical practice, and discuss what might constitute clinically meaningful change in these measures in relation to disease progression and treatment response.

Indexed as

Alzheimer DiseaseDisease ProgressionHumansOutcome Assessment, Health Careassessment toolsclinical meaningfulnessclinical trialsEarly Alzheimer’s diseaseendpoints

Identifiers

PMID35841252
PMCPMC9843702
OpenAlexW4226440463

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.