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NCT05531526 · ClinicalTrials.gov registry record · Phase 3

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 study of Alzheimer Disease, sponsored by AriBio Co..

Active
Registry status
Phase 3
Development phase
1,535
Enrollment target
20
Study locations

NCT05531526 is a Phase 3 study of Alzheimer Disease that is active but no longer recruiting, run by AriBio Co.. The registered enrollment target is 1,535 participants, below the 2,746-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 4 states.

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The verdict

NCT05531526, a Phase 3 study of Alzheimer Disease, is active but no longer recruiting, sponsored by AriBio Co..

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,535 participants
Enrollment target
20
Study locations

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 Studied

Alzheimer Disease

Interventions

  • DRUG Placebo
  • DRUG AR1001

Study Locations (20)

California

  • Sutter Health's Palo Alto Medical Foundation - Burlingame
  • Neuro-Pain Medical Center - Fresno
  • Fullerton Neurology and Headache Center - Fullerton
  • Esperanza Clinical - Murrieta
  • Valley Clinical Trials, INC - Northridge
  • Havana Research Institute - Pasadena
  • Kaizen Brain Center - San Diego
  • Adaptive Research - San Jose
  • The Neuron Clinic - San Marcos
  • Stanford Neuroscience Health Center - Stanford

Arizona

  • IMA Clinical Research Phoenix - Phoenix
  • Perseverance Research Center, LLC - Scottsdale
  • Clinical Endpoints - N. Scottsdale - Scottsdale
  • Banner Sun Health Research Institute - Sun City
  • Voyage Medical - Tempe

Colorado

  • Denver Neurological Research - Denver
  • Mile High Research Center - Denver
  • CenExel Rocky Mountain Clinical Research - Englewood

Florida

  • Topaz Clinical Research - Apopka
  • BayCare Health System, Inc - Clearwater

Trial Details

FieldValue
Enrollment Target 1,535 participants
Start Date 2022-12-23
Est. Completion 2027-12
Phase Phase 3

Sponsor

AriBio Co.

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05531526

The ClinicalTrials.gov registry entry for NCT05531526 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,535 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,746-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (44% lower). The listed sponsor is AriBio Co., which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05531526 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Colorado.

Frequently Asked Questions

What is clinical trial NCT05531526 about?

NCT05531526 is a clinical study titled "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)". 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.

What is the current status of trial NCT05531526?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,535 participants. The study started on 2022-12-23. Estimated completion is 2027-12.

What conditions does trial NCT05531526 study?

This clinical trial studies the following conditions: Alzheimer Disease.

What interventions are being tested in trial NCT05531526?

The interventions under investigation include: Placebo (DRUG), AR1001 (DRUG).

Who is sponsoring clinical trial NCT05531526?

This trial is sponsored by AriBio Co., which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05531526 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.