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vTv Therapeutics Presents Positive Data on the Effect of Azeliragon in Patients with Alzheimer’s and Diabetes at the 11th Clinical Trials on Alzheimer’s Disease (CTAD) Conference
Subgroup Analysis Indicates Potential Benefit of Treatment with Azeliragon for Patients with Type 2 Diabetes and Alzheimer’s Disease
Nearly 40 percent of Medicare Beneficiaries with Dementia Also Suffer from Diabetes, a Large Population to Potentially Benefit
In a poster presentation titled “Is RAGE the missing link between diabetes and dementia? Results from a subgroup analysis of the STEADFAST trial,” researchers from vTv reviewed results from a post-hoc subgroup analysis from the company’s STEADFAST trial. This subgroup included 55 patients with type 2 diabetes (defined by glycosylated hemoglobin (HbA1c) of greater than 6.5% at baseline; HbA1c greater than 7.7% was an exclusion criterion at screening) and a clinical diagnosis of Alzheimer’s disease in the combined A-Study and B-Study of the STEADFAST trial. The azeliragon-treated group in the A-Study (n=18) demonstrated a 6.1 point benefit on ADAS-cog relative to the placebo group (n=8), which was nominally statistically significant (p = 0.005), and a 1.7 point benefit on CDR-sb relative to placebo (p = 0.08) after 18 months of treatment.
When conducting this subgroup analysis on pooled data from both the A-Study and B-Study and comparing change from baseline at 12 months (B-Study was discontinued at 12 months), the azeliragon subgroup (n=33) demonstrated a 3.5 point benefit on ADAS-cog (p = 0.01) relative to the placebo group (n=22), and a 0.7 point benefit on CDR-sb (p = 0.24) relative to placebo. A copy of the poster can be found on the publications page of the company’s website.
“The association between diabetes and dementia is well documented and
these findings are supported by the mechanism of action of azeliragon.
The Receptor for Advance Glycation Endproducts (RAGE) has been
implicated in both the pathogenesis of Alzheimer’s disease and diabetic
complications. These results, albeit from a smaller number of patients,
reinforce this hypothesis and may open a new therapeutic approach for
the treatment of not only dementia but also other complications of
“We are encouraged by the positive benefits experienced by the diabetic
patients in this study.” said
Azeliragon, also known as TTP488, is an orally active small-molecule antagonist of the receptor for advanced glycation endproducts, RAGE. vTv Therapeutics discovered and developed azeliragon using its proprietary drug discovery platform, TTP Translational Technology®. A broad range of human pathologic and experimental biologic investigation suggests that RAGE ligand interactions lead to sustained inflammatory states that play a role in chronic diseases such as diabetes, inflammation, and Alzheimer’s disease.
The STEADFAST study, two independent and identical randomized,
double-blind, placebo-controlled Phase 3 trials (A-Study and B-Study),
was designed to investigate the safety and efficacy of azeliragon as a
potential treatment for patients with mild Alzheimer’s disease. The
18-month study targeted enrollment of 800 patients (400 in each trial).
The first trial enrolled patients in the United States and Canada who
had a clinical diagnosis of mild Alzheimer's disease and an MRI
consistent with this diagnosis. Enrollment of the second trial included
study sites in the United Kingdom, Ireland, Australia, New
Zealand and South Africa. While in April and in
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