Phase 3, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AR1001 in Participants With Early Alzheimer's Disease (Polaris-AD)
Phase 3, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AR1001 in Participants With Early Alzheimer's Disease (Polaris-AD)
ClinicalTrials.gov ID: NCT05531526
Sponsor: AriBio Co., Ltd.
Information provided by: AriBio Co., Ltd. (Responsible Party)
Last Update Posted: 2023-10-23
Brief Summary:
This AR1001-ADP3-US01 protocol is a double-blind, randomized, placebo-controlled, multi- center, parallel-group comparison pivotal Phase 3 study to evaluate the efficacy and safety of AR1001 for the treatment of participants with early AD.
Detailed Description:
The purpose of this Study is to evaluate the efficacy and safety of AR1001 in participants with Early Alzheimer's Disease (AD).
AR1001 is a small molecule that has demonstrated its potential as a therapeutic agent for AD via its polypharmacological characteristics with multiple mechanisms to ameliorate AD pathology.
AriBio completed a Phase 2 study in the United States (US) with AR1001 for the treatment of participants with mild to moderate AD. After confirming AR1001's therapeutic benefit in the mild AD population, AriBio is proceeding with a Phase 3 program in an early AD population including participants with MCI and mild dementia.
Official Title:
A Phase 3 Double-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of AR1001 Over 52 Weeks in Participants With Early Alzheimer's Disease (Polaris-AD)
Intervention / Treatment:
- Drug: AR1001
- Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2022-12-23 |
| Primary Completion (Estimated) | 2025-12 |
| Study Completion (Estimated) | 2027-12 |
| Enrollment (Estimated) | 1150 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
AC-22-027
|