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Rentz DM, Wessels AM, Annapragada AV, et al. Building clinically relevant outcomes across the Alzheimer's disease spectrum. Alzheimers Dement (N Y). 2021;7(1):e12181doi: 10.1002/trc2.12181.
Rentz, D. M., Wessels, A. M., Annapragada, A. V., Berger, A. K., Edgar, C. J., Gold, M., Miller, D. S., Randolph, C., Ryan, J. M., Wunderlich, G., Zoschg, M. C., Trépel, D., Knopman, D. S., Staffaroni, A. M., Bain, L. J., Carrillo, M. C., & Weber, C. J. (2021). Building clinically relevant outcomes across the Alzheimer's disease spectrum. Alzheimer's & dementia (New York, N. Y.), 7(1), e12181. https://doi.org/10.1002/trc2.12181
Rentz, Dorene M, et al. "Building clinically relevant outcomes across the Alzheimer's disease spectrum." Alzheimer's & dementia (New York, N. Y.) vol. 7,1 (2021): e12181. doi: https://doi.org/10.1002/trc2.12181
Rentz DM, Wessels AM, Annapragada AV, Berger AK, Edgar CJ, Gold M, Miller DS, Randolph C, Ryan JM, Wunderlich G, Zoschg MC, Trépel D, Knopman DS, Staffaroni AM, Bain LJ, Carrillo MC, Weber CJ. Building clinically relevant outcomes across the Alzheimer's disease spectrum. Alzheimers Dement (N Y). 2021 Jun 26;7(1):e12181. doi: 10.1002/trc2.12181. eCollection 2021. PMID: 34195350; PMCID: PMC8234696.
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Alzheimers Dement (N Y). 2021 Jun 26;7(1):e12181. doi: 10.1002/trc2.12181. eCollection 2021.

Building clinically relevant outcomes across the Alzheimer's disease spectrum.

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

Dorene M Rentz, Alette M Wessels, Ananth V Annapragada, Anna-Karin Berger, Chris J Edgar, Michael Gold, David S Miller, Christopher Randolph, J Michael Ryan, Glen Wunderlich, Megan Canniere Zoschg, Dominic Trépel, David S Knopman, Adam M Staffaroni, Lisa J Bain, Maria C Carrillo, Christopher J Weber

Affiliations

  1. Department of Neurology Massachusetts General Hospital Harvard Medical School Boston Massachusetts USA.
  2. Center for Alzheimer Research and Treatment Department of Neurology Brigham and Women's Hospital Harvard Medical School Boston Massachusetts USA.
  3. Eli Lilly and Company Indianapolis Indiana USA.
  4. E.B. Singleton Department of Radiology Texas Children's Hospital & Baylor College of Medicine Houston Texas USA.
  5. Lundbeck A/S Clinical Development Copenhagen Denmark.
  6. Cogstate Ltd London UK.
  7. AbbVie Inc., North Chicago Illinois USA.
  8. Signant Health Blue Bell Pennsylvania USA.
  9. WCG MedAvante-ProPhase Hamilton New Jersey USA.
  10. Department of Neurology Loyola University Medical Center Maywood Illinois USA.
  11. Rodin Therapeutics Cambridge Massachusetts USA.
  12. Boehringer Ingelheim (Canada) Ltd. Burlington Ontario Canada.
  13. F. Hoffmann-La Roche Ltd., Basel Basel-City Switzerland.
  14. Global Brain Health Institute Trinity College Dublin Dublin Ireland.
  15. School of Medicine Trinity College Dublin University of Dublin Dublin Ireland.
  16. Department of Neurology Mayo Clinic Rochester Minnesota USA.
  17. Memory and Aging Center Department of Neurology Weill Institute for Neurosciences University of California, San Francisco San Francisco USA.
  18. Independent Science Writer Elverson Pennsylvania USA.
  19. Alzheimer's Association Chicago Illinois USA.

PMID: 34195350 PMCID: PMC8234696 DOI: 10.1002/trc2.12181

Abstract

Demonstrating that treatments are clinically meaningful across the Alzheimer's disease (AD) continuum is critical for meeting our goals of accelerating a cure by 2025. While this topic has been a focus of several Alzheimer's Association Research Roundtable (AARR) meetings, there remains no consensus as to what constitutes a "clinically meaningful outcome" in the eyes of patients, clinicians, care partners, policymakers, payers, and regulatory bodies. Furthermore, the field has not come to agreement as to what constitutes a clinically meaningful treatment effect at each stage of disease severity. The AARR meeting on November 19-20, 2019, reviewed current approaches to defining clinical meaningfulness from various perspectives including those of patients and care partners, clinicians, regulators, health economists, and public policymakers. Participants discussed approaches that may confer clinical relevance at each stage of the disease continuum and fostered discussion about what should guide us in the future.

© 2021 the Alzheimer's Association.

Keywords: Alzheimer's disease; Research Roundtable; clinical meaningfulness; cognitive decline; dementia; treatment

Conflict of interest statement

AW is a full‐time employee and shareholder of Eli Lilly and Company. AA declares stock ownership and consulting fees from Alzeca Inc, stock ownership in Sensulin LLC. CJE is a full‐time employee of Co

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