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vTv Therapeutics to Present at the 14th International Conference on Alzheimer’s & Parkinson’s Diseases
Presentation of Results for Subgroup of Patients with Mild Alzheimer’s Disease and Type 2 Diabetes in the STEADFAST Study
The presentation will describe the post-hoc analyses of MRI brain volume measures, brain FDG-PET measures of glucose uptake and plasma markers of inflammation in a subgroup of patients with type 2 diabetes, defined as having glycosylated hemoglobin (HbA1c) greater than 6.5%, and mild Alzheimer’s disease in the azeliragon Phase 3 study, STEADFAST.
The results support the hypothesis that treatment with azeliragon may improve cognition and/or preserve function in patients with type 2 diabetes and mild Alzheimer’s disease, showing favorable trends for less whole brain atrophy, less ventricular enlargement, and smaller decreases in glucose uptake in the azeliragon-treated subgroup compared to placebo. Additionally, the results from the inflammatory marker analyses revealed changes consistent with RAGE inhibition, possibly indicating functional pharmacologic activity of azeliragon in this subgroup of patients.
Details of the presentations are below:
Abstract Number: ADPD9-2202
Abstract Title: Inflammatory Biomarkers, Brain Volumetric MRI, FDG-PET Results in Patients with Type 2 Diabetes in Azeliragon Phase 3 Trial in Mild Alzheimer’s Disease
SYMPOSIUM 57: AD TREATMENT STRATEGIES
The data will be available on the Publications page of the Company website following the presentation.
Azeliragon, also known as TTP488, is an orally active small-molecule antagonist of 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 AD.
The STEADFAST study, two independent and identical randomized,
double-blind, placebo-controlled Phase 3 trials (Part A and Part B), 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 also
included study sites in the United Kingdom, Ireland, Australia, New
Zealand and South Africa. In
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