Evidence map›Paper›PMID 41716297›Full record

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

Biomarkers in Alzheimer's disease clinical trials: 2025.

Amanda M Leisgang Osse, Yadi Zhou, Jefferson W Kinney, Andrew Hooyman, Ayan Sengupta, Jorge Fonseca, Aaron H Burstein, Meriel Owen, Laura Nisenbaum, Howard M Fillit and 2 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review 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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Review
  2. 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
  3. Advances in the treatment of Alzheimer's disease.Frontiers in pharmacology · 2026
    Review
  4. Review
  5. Biomarkers in Alzheimer's disease clinical trials: 2025.Alzheimer's & dementia (New York, N. Y.)
    Review
  6. 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.

Amanda M Leisgang OsseChambers-Grundy Center for Transformative Neuroscience Department of Brain Health Kirk Kerkorian School of Medicine University of Nevada Las Vegas (UNLV) Las Vegas Nevada USA.ORCID https://orcid.org/0000-0001-8351-2180
Yadi ZhouGenomic Medicine Institute Cleveland Clinic Research Cleveland Clinic Cleveland Ohio USA.
Jefferson W KinneyChambers-Grundy Center for Transformative Neuroscience Department of Brain Health Kirk Kerkorian School of Medicine University of Nevada Las Vegas (UNLV) Las Vegas Nevada USA.
Andrew HooymanDepartment of Physical Therapy Chapman University Irvine California USA.
Ayan SenguptaDepartment of Health Physics and Diagnostic Sciences School of Integrated Health Sciences University of Nevada Las Vegas (UNLV) Las Vegas Nevada USA.
Jorge FonsecaHoward R Hughes College of Engineering Department of Computer Science University of Nevada Las Vegas (UNLV) Las Vegas Nevada USA.
Aaron H BursteinAlzheimer's Drug Discovery Foundation (ADDF) New York New York USA.
Meriel OwenAlzheimer's Drug Discovery Foundation (ADDF) New York New York USA.
Laura NisenbaumAlzheimer's Drug Discovery Foundation (ADDF) New York New York USA.
Howard M FillitAlzheimer's Drug Discovery Foundation (ADDF) New York New York USA.
Feixiong ChengGenomic Medicine Institute Cleveland Clinic Research Cleveland Clinic Cleveland Ohio USA.
Jeffrey L 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

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
Translational and Therapeutics CoreP30AG072959 · NIA · CLEVELAND CLINIC LERNER COM-CWRU · PI JAGAN AYYAPPAN PILLAI · 2021 to 2026
$23.9M
Renewal of Centers of Biomedical Research Excellence (COBRE) (Phase 2) CNTN - ResubmissionP20GM109025 · NIGMS · CLEVELAND CLINIC FOUNDATION · PI Robert J. Fox, Jefferson Kinney · 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
Endophenotype Network-based Approaches to Prediction and Population-based Validation of In Silico Drug Repurposing for Alzheimer's DiseaseR01AG066707 · NIA · CLEVELAND CLINIC LERNER COM-CWRU · PI Feixiong Cheng · 2020 to 2026
$4.9M
TREM2 Genotype-Informed Drug Repurposing and Combination Therapy Design for Alzheimer’s DiseaseR01AG076448 · NIA · CLEVELAND CLINIC LERNER COM-CWRU · PI Feixiong Cheng, Li Gan · 2022 to 2026
$4.0M
Alzheimer's MultiOme Data Repurposing: Artificial Intelligence, Network Medicine, and Therapeutics DiscoveryU01AG073323 · NIA · CLEVELAND CLINIC LERNER COM-CWRU · PI BEKRIS, LYNN, CHENG, FEIXIONG · 2021 to 2025
$4.0M
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
Characterize neuronal and glial cell-specific vulnerability to proteinopathies in Alzheimer's disease using multimodal single-nuclei genomic and epigenomic approachesR01AG082118 · NIA · CLEVELAND CLINIC LERNER COM-CWRU · PI BONAKDARPOUR, BORNA, CHENG, FEIXIONG · 2023 to 2025
$2.4M
Dark GPCR signaling underlying the Microbiome-Gut-Brain Axis for Alzheimer's Disease and Related DementiaRF1NS133812 · NINDS · CLEVELAND CLINIC LERNER COM-CWRU · PI BROWN, JONATHAN MARK, CHENG, FEIXIONG · 2023 to 2023
$2.3M
Microglial Activation and Inflammatory Endophenotypes Underlying Sex Differences of Alzheimer’s DiseaseR01AG084250 · NIA · CLEVELAND CLINIC LERNER COM-CWRU · PI Feixiong Cheng, Justin D. Lathia · 2023 to 2026
$2.2M
NIA NIH HHS P20 AG068053NIA NIH HHS P30 AG072959NIA NIH HHS R01 AG053798NIA NIH HHS R01 AG066707NIA NIH HHS R01 AG076448NIA NIH HHS R01 AG082118NIA NIH HHS R01 AG084250NIA NIH HHS R01 AG092462NIA NIH HHS R01 AG092591NIA NIH HHS R33 AG083003NIA NIH HHS R35 AG071476NIA NIH HHS U01 AG073323NIGMS NIH HHS P20 GM109025NINDS NIH HHS RF1 NS133812NINDS NIH HHS U01 NS093334
6 · The paper itself

Abstract

Biomarkers play an important role in Alzheimer's disease (AD) clinical trials in several contexts of use, including defining trial eligibility and serving as outcome measures. Utilizing clinicaltrials.gov, a registry of clinical trials, we assessed biomarker usage across all active AD disease-targeted therapeutic (DTT) trials. Biomarkers are widely used in AD DTT trials, with 84% including a fluid, imaging, and/or digital biomarker, either as an inclusion criterion or as an outcome measure. In DTT trials, biomarkers were included in 83% of Phase 3 trials, 91% of Phase 2 trials, and 72% of Phase 1 trials. Biomarkers were used for trial inclusion in 58% of DTT trials and as a primary outcome measure in 36%. Characterization of biomarker usage in AD clinical trials offer valuable insights across the drug development spectrum, with the goal of increasing trial efficiency and interpretation, while reducing time for new therapies to become available.

Indexed as

Alzheimer's diseasebiomarkersclinical trialcommon Alzheimer's disease research ontologydrug development

Identifiers

PMID41716297
PMCPMC12914139

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.