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Alzheimer's Updates: Axsome's AXS-05, Semaglutide Trials, and Gut Microbiome Links

• Axsome Therapeutics' AXS-05 met its primary endpoint in a Phase III trial for Alzheimer's disease agitation, showing promise for managing this challenging symptom. • Clinical trials investigating semaglutide (Ozempic, Wegovy) as a potential early treatment for Alzheimer's disease are anticipated to conclude in 2025. • Research links Alzheimer's disease-associated CD83(+) microglia with increased immunoglobulin G4 and human cytomegalovirus in the gut, vagal nerve, and brain, suggesting a microbiome connection. • A phase IIa trial showed that nicotinamide was safe but did not alter Alzheimer's biomarkers in people with mild cognitive impairment or mild dementia.

Axsome Therapeutics has announced positive results from its ACCORD-2 phase III trial of AXS-05 (dextromethorphan-bupropion) in patients with agitation related to Alzheimer's disease. The trial met its primary endpoint, offering a potential new treatment option for this common and distressing symptom.

Semaglutide as a Potential Alzheimer's Therapy

Two clinical trials are underway to evaluate semaglutide (Ozempic, Wegovy) as a possible early intervention for Alzheimer's disease. Results from these trials are expected in 2025, and could offer a novel approach to disease modification.

Gut Microbiome and Alzheimer's Disease

Emerging research suggests a link between the gut microbiome and Alzheimer's disease. A recent study found that Alzheimer's disease-associated CD83(+) microglia were associated with increased immunoglobulin G4 and human cytomegalovirus in the gut, vagal nerve, and brain, highlighting a potential role for the gut-brain axis in the pathogenesis of Alzheimer's.

Other Alzheimer's Updates

A phase IIa trial investigating nicotinamide in individuals with mild cognitive impairment or mild dementia found the treatment to be safe but ineffective in altering Alzheimer's biomarkers.
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Reference News

[1]
Alzheimer's and Gut Infection; Novel Tau Therapy; Kids' Brain Structure and Drug Use
medpagetoday.com · Dec 31, 2024

CD83(+) microglia linked to Alzheimer's show increased IgG4 and human cytomegalovirus presence. Nicotinamide safe but in...

[2]
Ozempic for Alzheimer's? What Drives Brain Age; Primary Care Alzheimer's Guideline
medpagetoday.com · Dec 24, 2024

Clinical trials on semaglutide for Alzheimer's, stem cell treatments for Parkinson's/epilepsy, vascular health linked to...

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