NCT05531526

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)

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,535 (actual)
• Sponsor: AriBio Co., Ltd. · Industry
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	AR1001	AR1001 Active Oral Tablet
DRUG	Placebo	Placebo Oral Tablet

Timeline

• Start date: 2022-12-23
• Primary completion: 2026-05-01
• Completion: 2027-12-01
• First posted: 2022-09-08
• Last updated: 2025-10-02

Locations

198 sites across 13 countries: United States, Canada, China, Czechia, Denmark, France, Germany, Italy, Netherlands, Poland, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study