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Target product profiles for treatments to delay or prevent symptomatic Alzheimer’s disease

Cummings, Jeffrey L. ; Agadjanyan, Michael G. ; Barry, Maureen ; Corey, Lawrence ; Doody, Rachelle ; Hendrix, Suzanne ; Mattke, Soeren ; Mattsson-Carlgren, Niklas LU orcid ; McDade, Eric and Menetski, Joseph P. , et al. (2026) In Nature Medicine 32(4). p.1223-1232
Abstract

Despite advances in understanding the mechanisms, risk factors and treatment strategies for Alzheimer’s disease (AD), no approved therapies exist to prevent or delay onset in at-risk individuals or those with elevated biomarkers who do not yet show symptoms. Multiple candidate interventions are now being evaluated in clinical trials in these settings, raising key questions around which populations are most appropriate and what criteria should guide regulatory and clinical decision-making. Data are expected within 1–2 years, underscoring the need for stakeholder alignment on clinically meaningful and acceptable characteristics of preventative therapies or other products. To address this need, the Global CEO Initiative on Alzheimer’s... (More)

Despite advances in understanding the mechanisms, risk factors and treatment strategies for Alzheimer’s disease (AD), no approved therapies exist to prevent or delay onset in at-risk individuals or those with elevated biomarkers who do not yet show symptoms. Multiple candidate interventions are now being evaluated in clinical trials in these settings, raising key questions around which populations are most appropriate and what criteria should guide regulatory and clinical decision-making. Data are expected within 1–2 years, underscoring the need for stakeholder alignment on clinically meaningful and acceptable characteristics of preventative therapies or other products. To address this need, the Global CEO Initiative on Alzheimer’s Disease convened an international group of experts to develop target product profiles for therapies designed to delay or prevent the onset of clinical symptoms in AD. These target product profiles outline minimum and preferred characteristics, including intended use, target populations, safety expectations and efficacy benchmarks. This effort provides a foundational framework to accelerate therapeutic development and guide researchers, regulators and patients in the evaluation of emerging therapies for preventing symptomatic AD.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Nature Medicine
volume
32
issue
4
pages
10 pages
publisher
Nature Publishing Group
external identifiers
  • pmid:41933174
  • scopus:105034890479
ISSN
1078-8956
DOI
10.1038/s41591-026-04305-w
language
English
LU publication?
yes
id
691b5d5f-b1a6-45cf-8853-1d32fb22e6fb
date added to LUP
2026-07-07 10:04:03
date last changed
2026-09-02 02:56:10
@article{691b5d5f-b1a6-45cf-8853-1d32fb22e6fb,
  abstract     = {{<p>Despite advances in understanding the mechanisms, risk factors and treatment strategies for Alzheimer’s disease (AD), no approved therapies exist to prevent or delay onset in at-risk individuals or those with elevated biomarkers who do not yet show symptoms. Multiple candidate interventions are now being evaluated in clinical trials in these settings, raising key questions around which populations are most appropriate and what criteria should guide regulatory and clinical decision-making. Data are expected within 1–2 years, underscoring the need for stakeholder alignment on clinically meaningful and acceptable characteristics of preventative therapies or other products. To address this need, the Global CEO Initiative on Alzheimer’s Disease convened an international group of experts to develop target product profiles for therapies designed to delay or prevent the onset of clinical symptoms in AD. These target product profiles outline minimum and preferred characteristics, including intended use, target populations, safety expectations and efficacy benchmarks. This effort provides a foundational framework to accelerate therapeutic development and guide researchers, regulators and patients in the evaluation of emerging therapies for preventing symptomatic AD.</p>}},
  author       = {{Cummings, Jeffrey L. and Agadjanyan, Michael G. and Barry, Maureen and Corey, Lawrence and Doody, Rachelle and Hendrix, Suzanne and Mattke, Soeren and Mattsson-Carlgren, Niklas and McDade, Eric and Menetski, Joseph P. and Mohs, Richard C. and Partrick, Katherine A. and Petrovsky, Nikolai and Selkoe, Dennis J. and Silva, Diego and Sperling, Reisa A. and Tiede, Benjamin and Vradenburg, George}},
  issn         = {{1078-8956}},
  language     = {{eng}},
  number       = {{4}},
  pages        = {{1223--1232}},
  publisher    = {{Nature Publishing Group}},
  series       = {{Nature Medicine}},
  title        = {{Target product profiles for treatments to delay or prevent symptomatic Alzheimer’s disease}},
  url          = {{http://dx.doi.org/10.1038/s41591-026-04305-w}},
  doi          = {{10.1038/s41591-026-04305-w}},
  volume       = {{32}},
  year         = {{2026}},
}