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Active, not recruiting Phase 3 Interventional Accepts healthy volunteers

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 Sep 1, 2026, 11:10 PM 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
Accepts healthy volunteers

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

Study timeline

Start date
Dec 22, 2022
Primary completion
Apr 30, 2026
Completion
Nov 30, 2027
Last update posted
Oct 1, 2025

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 1, 2025 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05531526 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →