vTv Therapeutics Enrolling People with Mild Alzheimer’s for Phase 3 Study of Oral Therapy

vTv Therapeutics Enrolling People with Mild Alzheimer’s for Phase 3 Study of Oral Therapy
vTv Therapeutics is recruiting patients for a large Phase 3 study, known as STEADFAST, assessing the drug azeliragon as a potential treatment for mild Alzheimer's disease (AD). Study participants will be randomly assigned to take either a 5 mg pill containing azeliragon once a day, or a placebo (sugar pill), for 18 months, with the drug's effectiveness determined through cognitive tests. Azeliragon is a small inhibitory molecule that blocks a receptor called RAGE (receptor of advanced glycation endproducts), which is thought to contribute to amyloid plaque deposits in the brain. Amyloid is a protein that, along with hyperphosphorylated tau, is believed to cause Alzheimer's brain cell death and the associated symptoms of AD. There are no current approved medications for AD that target amyloid. While a Phase 2b study of azeliragon conducted in 399 people with mild-to-moderate Alzheimer’s was stopped prematurely for an apparent failure to show benefits (particularly its 20 mg arm), the company reported in a follow-up analysis a statistically significant improvement in cognitive measures (ADAS-Cog scores) and significantly lower rate of psychiatric events like anxiety in patients treated with azeliragon at 5 mg versus placebo for 18 months. The greatest improvements in two cognitive measures — ADAS-Cog scores and clinical dementia ratings (CDR) — were seen in those with mild disease treated at 5 mg. The 18 months of treatment given allowed for this follow-up analysis, and these results were determined by regulatory agencies to merit a larger and more advanced study, using the 5 mg dose. Preclinical studies in mice also showed a dec
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