Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Jan;15(1):172-178.
doi: 10.1016/j.jalz.2018.05.006. Epub 2018 Jun 21.

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

Jeffrey Cummings  1
Affiliations

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

Jeffrey Cummings. Alzheimers Dement. 2019 Jan.

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.

Keywords: Alzheimer's disease; Amyloid; Biomarkers; Clinical trials; Disease modification; NIA-AA Framework; Neurodegeneration; Tau.

PubMed Disclaimer

References

    1. Jack CR Jr., Bennett DA, Blennow K, Carrillo MC, Dunn B, Elliott C, et al. NIA-AA research framework: towards a biological definition of Alzheimer’s disease. Alzheimer Dement 2018;14:535–62. - PMC - PubMed
    1. Jack CR Jr., Bennett DA, Blennow K, Carrillo MC, Feldman HH, Frisoni GB, et al. A/T/N: An unbiased descriptive classification scheme for Alzheimer disease biomarkers. Neurology 2016;87:539–47. - PMC - PubMed
    1. U.S. Food and Drug Administration. Early Alzheimer’s disease: developing drugs for treatment; draft guidance for industry. Federal Register; 2018. p. 7060–1.
    1. Kennedy ME, Stamford AW, Chen X, Cox K, Cumming JN, Dockendorf MF, et al. The BACE1 inhibitor verubecestat (MK-8931) reduces CNS beta-amyloid in animal models and in Alzheimer’s disease patients. Sci Transl Med 2016;8:363ra150. - PubMed
    1. Reiman EM, Langbaum JB, Fleisher AS, Caselli RJ, Chen K, Ayutyanont N, et al. Alzheimer’s Prevention Initiative: a plan to accelerate the evaluation of presymptomatic treatments. J Alzheimers Dis 2011;26 Suppl 3:321–9. - PMC - PubMed

Publication types