The National Institute on Aging—Alzheimer's Association Framework on Alzheimer's disease: Application to clinical trials

Cummings, Jeffrey

doi:10.1016/j.jalz.2018.05.006

Cited by 141Dementia and Cognitive Impairment ResearchAlzheimer's disease research and treatmentsNeuroinflammation and Neurodegeneration Mechanisms

The National Institute on Aging—Alzheimer's Association Framework on Alzheimer's disease: Application to clinical trials

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Cummings, Jeffrey·2019·Alzheimer's & Dementia

DOI 10.1016/j.jalz.2018.05.006PMC PMC6417790

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Abstract

Introduction: The National Institute on Aging—Alzheimer's Association Research Framework on Alzheimer's disease (AD) represents an important advance in the biological characterization of the AD spectrum. Methods: The National Institute on Aging—Alzheimer's Association Framework is considered as it applies to clinical trials. Results: Using the combination of amyloid (A), tau (T), and neurodegeneration (N) biomarkers, the Framework provides a means of defining the state of patients with regard to Alzheimer pathologic change. The Framework is relevant to clinical trials of disease‐modifying agents, allowing participants to be characterized biologically at baseline. The ATN Framework can also inform trial outcomes. The preclinical phase of the disease after amyloid deposition is defined by A+T−N−, and the transition to prodromal disease and dementia is characterized by the addition of T and N. Most symptomatic patients in clinical trials are in the class of A+T+N− and A+T+N+. Discussion: The National Institute on Aging—Alzheimer's Association Framework on AD represents progress in providing biomarker profiles of participants in the AD spectrum that can be used to help design clinical trials.

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Authors: Cummings, J.
Affiliations: Cleveland Clinic (US)
Corresponding author: Cummings, Jeffrey
ORCID: Cummings, Jeffrey
Venue: Alzheimer's & Dementia
Publisher: Wiley
Published: 2018-06-21
Volume: 15
Issue: 1
Pages: 172-178
ISSN: 1552-5260 (ISSN-L)
1552-5279
DOI: 10.1016/j.jalz.2018.05.006
PMC: PMC6417790
OpenAlex: W2809499549
Cited by: 140
References: 54
Citations by year: 2026: 13 · 2025: 12 · 2024: 25 · 2023: 18 · 2022: 12 · 2021: 21 · 2020: 21 · 2019: 18
FWCI: 11.72
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc-nd
creativecommons.org/licenses/by-nc-nd/4.0/ (vor)
Locations: Alzheimer s & Dementia (publishedVersion, cc-by-nc-nd)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Digital Scholarship - UNLV (University of Nevada Reno) (submittedVersion, cc-by-nc-nd)
Funders: National Institutes of Health
National Institute of General Medical Sciences (P20GM109025)
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
Life Sciences › Neuroscience › Neurology › Neuroinflammation and Neurodegeneration Mechanisms
Keywords: Alzheimer's disease
MeSH terms: Alzheimer Disease, Clinical Trials as Topic, Humans, United States, Biomarkers, National Institute on Aging (U.S.)

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The National Institute on Aging—Alzheimer's Association Framework on Alzheimer's disease: Application to clinical trials

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