NIH grant: Uncovering the Therapeutic Potential of Semaglutide in Alzheimer's Disease: Insights from Animal Models and Real-World Clinical Data (1R01AG099323-01)

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NIH grant 1R01AG099323-01: Uncovering the Therapeutic Potential of Semaglutide in Alzheimer's Disease: Insights from Animal Models and Real-World Clinical Data
Institute: {'code': 'AG', 'abbreviation': 'NIA', 'name': 'National Institute on Aging', 'admin_org_id': '12500002', 'admin_funding_url': ''}. PI: XIN  QI. Award: $655673.
Start: 2026-08-15T00:00:00.
PROJECT SUMMARY
Alzheimer's disease (AD) is the most common cause of dementia and a leading cause of morbidity and mortality
in the aging population. An estimated 6.9 million Americans aged 65 and older live with AD in 2024, a number
projected to increase to 13.8 million by 2060. AD inevitably progresses and patients die within an average of 4
to 8 years after diagnosis. Currently,
there is no cure available.
Therefore, there is an urgent need for novel
therapeutic strategies. Emerging evidence suggests that semaglutide (Ozempic and Wegovy) and tirzepatide
(Mounjaro and Zepbound), a new generation of GLP-1 receptor agonists (GLP-1RAs) approved for treating type
2 diabetes and weight loss, could offer a promising therapeutic approach for AD. Currently, two clinical trials
(sponsored by Novo Nordisk) are ongoing to examine semaglutide in patients with early AD. No clinical trials
are ongoing to test semaglutide in patients with later stages of AD. No clinical trials are ongoing for testing
tirzepatide in AD. Additionally, mechanisms underlying potential therapeutic benefits of semaglutide and
tirzepatide in AD remain largely unknown. Our proposal titled “Uncovering the Therapeutic Potential of
Semaglutide and Tirzepatide in Alzheimer's Disease: Insights from Animal Models and Real-World
Clinical Data” aims to address several critical but unanswered questions: 1) can semaglutide improve clinical
outcomes in real-world patients with later stages of AD? 2) will tirzepatide offer similar or even more
profound benefits in AD treatment? 3) which specific AD patients will benefit most? 4) what are the
underlying mechanisms?
This agile 3-year project will collect timely data on the therapeutic efficacy of semaglutide and tirzepatide across
a wide range of clinical outcomes in real-world patients with AD, including those in later stages. It will identify
which specific subgroups of AD patients are most likely to benefit from these treatments. This project will provide
in-depth mechanistic insights into the effects of these drugs using AD transgenic mice. This research will
complement and significantly expand upon existing clinical trials, offering robust real-world and mechanistic
evidence to support the therapeutic benefits of semaglutide and tirzepatide that could move precision medicine
approaches for AD drug discovery in a new direction.

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