Phase 3Active, not recruitingAge-related condition
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 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)
- Sponsor
- AriBio Co., Ltd. (Industry)
- Enrolment
- 1,535 enrolled
- Conditions
- Alzheimer Disease
- Interventions
- AR1001; Placebo
- Ages
- adults, older adults
- Registry
- NCT05531526
Full record on ClinicalTrials.gov
From the registry
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 outcomes
- Change from Baseline in the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) (Overall Population)
- Change from Baseline in the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) (Monotherapy Population)
History
Study completion expected
Last registry update
Primary completion
Started
Registered