Baseline characteristics for participants enrolled in a phase 2/3 study, Elevage (NCT03980730), of azeliragon (vTv Therapeutics, High Point, NC) for mild Alzheimer disease (AD) in people with type 2 diabetes have been reported. In an earlier phase 3 study of azeliragon, STEADFAST(NCT02080364), benefits of treatment were seen for a subgroup of participants with type II diabetes in post hoc analysis, although efficacy was not seen for the intention-to-treat population.
In the new phase 2/3 study, Elevage, participants are age 50 to 85 with type II diabetes and probable mild AD. These characteristics match that of 47 participants treated with azeliragon in STEADFAST who, on post-hoc analysis, had a 5.5-point improvement in Alzheimer Disease Assessment Scale-Cognitive subscale (ADAS-Cog) scores compared with those given placebo. The new trial will test the resulting hypothesis that azeliragon may have efficacy for treatment of mild AD in people with type II diabetes.
“We have completed enrollment in part 1 of Elevage and are pleased that the baseline characteristics are consistent with those of the STEADFAST subgroup in which we saw benefit for azeliragon compared with placebo,” said Steve Holcombe, president and CEO, vTv Therapeutics. “The Elevage study for azeliragon in this patient population is designed as sequential phase 2 and phase 3 trials operationally conducted under one protocol. If the phase 2 data are positive, this design would allow us to move quickly to a phase 3 trial with the potential to support product approval.”