vTv Therapeutics to Detail Potential Alzheimer’s Treatment, Now in Phase 3 Study, at Meeting Today

Larry Altstiel, MD, PhD, chief medical officer of vTv Therapeutics, will speak today on the panel “Novel Approaches to Alzheimer’s Disease,” during the Neuro Advance Boston conference hosted by Harvard Medical School.

Altstiel will detail the mechanisms of action of azeliragon, vTv Therapeutics’ investigative treatment for mild Alzheimer’s disease (AD), in his Oct. 5 presentation, according to a press release. The treatment is currently in a Phase 3 clinical trial in people with mild Alzheimer’s, which is recruiting patients.

Azeliragon blocks the receptor RAGE (Receptor for Advanced Glycation Endproducts) in the brain. Normally found in low numbers in a healthy brain, RAGE numbers increase during inflammation. Examinations of deceased Alzheimer’s patients and biologic investigations indicate that RAGE numbers seem to correlate with AD severity and progression. RAGE in higher number affects both neurons and glial cells in the brain, and is also linked to blood vessel dysfunction — another key factor that influences dementia development.

Preclinial studies have shown that blocking the receptor RAGE impacts several processes that researchers believe contribute to Alzheimer’s. It reduces the accumulation of amyloid-beta and prevents the formation of fibrils made up of the tau protein. Azeliragon also dampens brain inflammation.

At the Alzheimer’s Association International Conference 2016, held in Toronto in June, vTv Therapeutics presented data from a Phase 2b clinical trial of 399 patients with mild to moderate Alzheimer’s disease, who had been treated with cholinesterase inhibitors or Namenda (memantine). In this study, treatment with azeliragon (5mg) was found to slow cognitive decline in these patients.

The current study, STEADFAST (NCT02080364), is assessing the efficacy and safety of azeliragon for mild AD. A projected total of 800 people will be randomized to either oral once daily azeliragon treatment, a 5 mg pill, or placebo (sugar pill), for 18 months, with the drug’s effectiveness determined through cognitive tests.

Requirements for participation in the STEADFAST study include a diagnosis of “probable” AD with documented evidence that the disease has progressed. The diagnosis needs to be based both on brain imaging through MRI and standard tests for cognitive problems.

The trial is being conducted at some 120 locations throughout the United States, Canada, Australia, New Zealand, the U.K., and South Africa. People who are interested in taking part can contact Dr. Aaron H. Burstein at [email protected]. More information is also available on the study’s clinical trials.gov webpage, or by clicking on its identification number above.