Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease
Summary
This is a study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer's disease. Patients will receive either azeliragon or placebo with a patient's participation lasting approximately 18 months.
Timeline
- Start
- 2015-04
- Primary completion
- 2018-06-01
- Completion
- 2018-06-01
Outcome
Missed primary endpoint
Stopped: “Not due to safety but due to a lack of efficacy at the 5 mg azeliragon dose.”
registry analysis (superiority test); A-Study: Azeliragon vs A-Study: Placebo; p = 0.3386; Mixed Models Analysis; note: p-value for comparison to Placebo NCT02080364 ↗
registry analysis (superiority test); B-Study: Azeliragon vs B-Study: Placebo; p = 0.1992; Mixed Models Analysis; note: p-value for compairons to Placebo NCT02080364 ↗
registry analysis (superiority test); A-Study: Azeliragon vs A-Study: Placebo; p = 0.9394; Mixed Models Analysis; note: p-value for comparison to Placebo. NCT02080364 ↗
release “STEADFAST study of the investigational medication azeliragon in people with mild Alzheimer’s disease did not meet either co-primary efficacy endpoint.” vtvtherapeutics.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azeliragon | Small molecule | 5 mg | Oral |