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Active, not recruiting Phase 3 Interventional

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

Public ClinicalTrials.gov record NCT05531526. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 11:30 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05531526
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
AriBio Co., Ltd.
Industry
Enrollment
1,535 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
55 Years to 90 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 23, 2022 (Actual)
Primary completion
Jun 29, 2026 (Actual)
Completion
Oct 2027 (Estimated)
Last update posted
Oct 14, 2026

2022 – 2027

United States locations

U.S. sites
75
U.S. states
24
U.S. cities
65
Facility City State ZIP Site status
IMA Clinical Research Phoenix Phoenix Arizona 85012 —
Perseverance Research Center, LLC Scottsdale Arizona 85253 —
Clinical Endpoints - N. Scottsdale Scottsdale Arizona 85258 —
Banner Sun Health Research Institute Sun City Arizona 85351 —
Voyage Medical Tempe Arizona 85282 —
Sutter Health's Palo Alto Medical Foundation Burlingame California 94010 —
Neuro-Pain Medical Center Fresno California 93710 —
Fullerton Neurology and Headache Center Fullerton California 92835 —
Esperanza Clinical Murrieta California 92562 —
Valley Clinical Trials, INC Northridge California 91325 —
Havana Research Institute Pasadena California 91105 —
Kaizen Brain Center San Diego California 92037 —
Adaptive Research San Jose California 95124 —
The Neuron Clinic San Marcos California 92069 —
Stanford Neuroscience Health Center Stanford California 94305 —
Denver Neurological Research Denver Colorado 80210 —
Mile High Research Center Denver Colorado 80218 —
CenExel Rocky Mountain Clinical Research Englewood Colorado 80113 —
Topaz Clinical Research Apopka Florida 32803 —
BayCare Health System, Inc Clearwater Florida 33756 —
Vertex Research Group Clermont Florida 34711 —
Arrow Clinical Trial Daytona Beach Florida 32117 —
Brainstorm Research - Loxahatchee Loxahatchee Groves Florida 33470 —
ClinCloud LLC Maitland Florida 32751 —
Verus Clinical Research, Corp Miami Florida 33135 —
Vitae Research Center, LLC Miami Florida 33135 —
Caro Medcenter and Community Research Miami Florida 33145 —
Allied Biomedical Research Institute, Inc Miami Florida 33155 —
Future Life Clinical Trials Miami Florida 33169 —
Brainstorm Research Miami Florida 33176 —
Meridian International Research, Inc Miami Gardens Florida 33014 —
Charter Research - Orlando Orlando Florida 32803 —
K2 Medical Research Orlando Florida 32806 —
JEM Research Institute Palm Beach Florida 33462 —
Progressive Medical Research Port Orange Florida 32127 —
Angels Clinical Research Institute, Inc. - Tampa Tampa Florida 33614 —
Charter Research - The Villages The Villages Florida 32162 —
ClinCloud, LLC Melbourn Viera Florida 32940 —
Conquest Research Winter Park Florida 32789 —
iResearch -Atlanta Atlanta Georgia 30030 —
Atlanta Neuroscience Institute Atlanta Georgia 30327 —
Accel Research Sites Decatur Georgia 30030 —
iResearch Savannah Georgia 31405 —
Re:Cognition Health - Chicago Chicago Illinois 60611 —
Tandem Clinical Research New Orleans Louisiana 70072 —
BTC of New Bedford New Bedford Massachusetts 02740 —
Boston Center for Memory Newton Massachusetts 02459 —
Headlands Research - Eastern MA Plymouth Massachusetts 02360 —
Boston Paincare Waltham Massachusetts 02451 —
Sharlin Health Neuroscience Research Center Ozark Missouri 65721 —
Alivation Lincoln Nebraska 68526 —
Wake Research- Clinical Research Center of Nevada, LLC Las Vegas Nevada 89106 —
Advanced Memory Research Institute of New Jersey Toms River New Jersey 08755 —
Dent Neuroscience Research Center Amherst New York 14226 —
Mid-Hudson Medical Research, PLLC - New Windsor New Windsor New York 12553 —
Triad Clinical Trials Greensboro North Carolina 27410 —
AMC Research, LLC Matthews North Carolina 28105 —
Accellacare of Winston-Salem, Triad Neurological Associates Winston-Salem North Carolina 27103 —
NeuroScience Research Center, LLC Canton Ohio 44718 —
American Clinical Research Institute, LLC Dayton Ohio 45432 —
Rhode Island Mood and Memory REsearch East Providence Rhode Island 02914 —
Health Concepts Rapid City South Dakota 57702 —
Neurology Clinic, P.C. Cordova Tennessee 38018 —
Center for Biomedical Research, LLC - Genesis Neuroscience Clinic Knoxville Tennessee 37909 —
Gadolin Research LLC Beaumont Texas 77702 —
Kerwin Medical Center Dallas Texas 75231 —
Cognition Health Corporation- Texas Houston Texas 77030 —
Clinical Trial Network - Houston Houston Texas 77074 —
Bhupesh Dihenia, MD, PA Lubbock Texas 79410 —
Wasatch Clinical Research, LLC Salt Lake City Utah 84107 —
Cognition Health Corporation Fairfax Virginia 22031 —
Integrated Neurology Services Falls Church Virginia 22043 —
Kingfisher Cooperative Spokane Washington 99201 —
Vaught Neurological Services, PLLC Crab Orchard West Virginia 25827 —
Medical College of Wisconsin Wauwatosa Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 123 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05531526, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 14, 2026 · Synced Oct 17, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05531526 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →