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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)

NCT05531526 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1535

Last updated 2025-10-02

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease

Interventions

DRUG

AR1001

AR1001 Active Oral Tablet

DRUG

Placebo

Placebo Oral Tablet

Sponsors & Collaborators

  • AriBio Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • James Rock · AriBio Co., Ltd.

  • Sharon Sha, MD, MS · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-23
Primary Completion
2026-05-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05531526 on ClinicalTrials.gov