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Peer-reviewedCC BY-NC-NDAlzheimer's & dementia : the journal of the Alzheimer's Association

Expert perspectives on the design and communication of endpoints in Alzheimer's disease clinical trials.

4 more authors
12 affiliations
  1. 1Banner Alzheimer's Institute and University of Arizona College of Medicine, Phoenix, Arizona, USA.
  2. 2Pentara Corporation, Salt Lake City, Utah, USA.
  3. 3Global Alzheimer's Platform Foundation, Washington, District of Columbia, USA.
  4. 4Bristol Myers Squibb, Princeton, New Jersey, USA.
  5. 5Perelman School of Medicine, University of Pennsylvania, Philadelphia, New Jersey, USA.
  6. 6ki:elements GmbH, Saarbrücken, Germany.
  7. 7Department of Clinical Pharmacy, University of Colorado Anschutz, Aurora, Colorado, USA.
  8. 8UsAgainstAlzheimer's, Washington, District of Columbia, USA.
  9. 9The Global CEO Initiative on Alzheimer's Disease, Wayne, Pennsylvania, USA.
  10. 10Department of Psychiatry and Psychotherapy, LMU Hospital, Ludwig-Maximilians-University, Munich, Germany.
  11. 11Department of Neurology, Knight Alzheimer's Disease Research Center, Washington University School of Medicine, St. Louis, Missouri, USA.
  12. 12Voices of Alzheimer's, Washington, District of Columbia, USA.

Abstract

Disease-targeted therapies (DTTs) for Alzheimer's disease (AD) represent a major advance, yet challenges remain on how best to interpret and communicate their benefits. As clinical development increasingly targets the earliest stages of AD (before symptoms emerge and early symptomatic AD), there is a need for novel, complementary endpoints and improved communication of treatment benefits. The Global CEO Initiative on Alzheimer's Disease convened a multi-stakeholder working group to develop recommendations for improving the design and communication of endpoints in AD clinical trials. In the near term, communication can be improved by contextualizing treatment effects at the individual level, including framing benefits in terms of responder analyses and "time saved" over defined timeframes. In parallel, continued development of complementary endpoints is needed to enable more sensitive, scalable, and patient-centered measurements aligned with early intervention. These recommendations aim to support stakeholders in evaluating and communicating the meaningful benefits of current and emerging therapies.

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BibTeX
@article{tariot2026expert,
  title = {{Expert perspectives on the design and communication of endpoints in Alzheimer's disease clinical trials.}},
  author = {Pierre N Tariot and Samuel P Dickson and John Dwyer and Carlos Granda and Lynne Hughes and Jason Karlawish and Nicklas Linz and Kavita V Nair and Russ Paulsen and Daniel Pawson and Robert Perneczky and Suzanne E Schindler and Emily Scholler and James Taylor and Benjamin Tiede and George Vradenburg},
  journal = {Alzheimer's \& dementia : the journal of the Alzheimer's Association},
  year = {2026},
  month = oct,
  doi = {10.1002/alz.71951},
  url = {https://europepmc.org/article/MED/42963333},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - Expert perspectives on the design and communication of endpoints in Alzheimer's disease clinical trials.
AU  - Pierre N Tariot
AU  - Samuel P Dickson
AU  - John Dwyer
AU  - Carlos Granda
AU  - Lynne Hughes
AU  - Jason Karlawish
AU  - Nicklas Linz
AU  - Kavita V Nair
AU  - Russ Paulsen
AU  - Daniel Pawson
AU  - Robert Perneczky
AU  - Suzanne E Schindler
AU  - Emily Scholler
AU  - James Taylor
AU  - Benjamin Tiede
AU  - George Vradenburg
PY  - 2026
DA  - 2026/10/01
JO  - Alzheimer's & dementia : the journal of the Alzheimer's Association
DO  - 10.1002/alz.71951
UR  - https://europepmc.org/article/MED/42963333
AB  - Disease-targeted therapies (DTTs) for Alzheimer's disease (AD) represent a major advance, yet challenges remain on how best to interpret and communicate their benefits. As clinical development increasingly targets the earliest stages of AD (before symptoms emerge and early symptomatic AD), there is a need for novel, complementary endpoints and improved communication of treatment benefits. The Global CEO Initiative on Alzheimer's Disease convened a multi-stakeholder working group to develop recommendations for improving the design and communication of endpoints in AD clinical trials. In the near term, communication can be improved by contextualizing treatment effects at the individual level, including framing benefits in terms of responder analyses and "time saved" over defined timeframes. In parallel, continued development of complementary endpoints is needed to enable more sensitive, scalable, and patient-centered measurements aligned with early intervention. These recommendations aim to support stakeholders in evaluating and communicating the meaningful benefits of current and emerging therapies.
SN  - 1552-5260
SN  - 1552-5279
ER  -