Target product profiles for treatments to delay or prevent symptomatic Alzheimer's disease
Summary
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.
Content
# Target product profiles for treatments to delay or prevent symptomatic Alzheimer's disease
*Published: 2026 Apr*
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.
DOI: 10.1038/s41591-026-04305-w