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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: Active Phase 3 study of Alzheimer Disease, sponsored by AriBio Co..
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in the CDR-SB from Baseline to Week 52
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,535 participants |
| Start Date | 2022-12-23 |
| Est. Completion | 2027-12 |
| Phase | Phase 3 |
What the registry record for NCT05531526 still lists
NCT05531526 is an interventional study that assigns participants to a tested intervention. Its 1,535 participants enrollment target places it among the larger protocols in the corpus, below the 2,746-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (44% lower).
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 names 20 study sites across 4 states, led by 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.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05531526's enrollment target sits among peer trials
1,535 26th of 306 higher than 281 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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