Adaptive Research has announced that community practices within its network have begun enrolling patients in AriBio's Phase 3 POLARIS-AD clinical trial. This trial (NCT05531526) is a double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of AR1001 in individuals with early Alzheimer's disease. The study aims to enroll 1150 participants globally to assess AR1001's potential in slowing the progression of Alzheimer's.
The POLARIS-AD trial is a multi-center study that will evaluate the efficacy and safety of AR1001 over 52 weeks. The trial incorporates various cognitive and functional assessments to measure the drug's impact on slowing Alzheimer's progression. Community sites are crucial for recruiting diverse study populations, reducing inequalities in clinical trial enrollment related to age, geography, and ethnicity.
Importance of Community-Based Trial Sites
Deepak Behera, MD, President and CEO of Adaptive Research, emphasized the importance of including community sites in Alzheimer's clinical trials. "Travel time to academic settings can contribute to inequalities in Alzheimer's disease clinical trial enrollment due to age, geography, and ethnicity," said Dr. Behera. "To recruit study populations that reflect the treatment population and make it easier for them to stay in the study, Sponsors need sites closer to patients that can produce quality data. In fact, community sites tend to know the patient population better resulting in a lower screen fail rate and better patient retainment compared to other settings."
AriBio's Perspective
James Rock, Chief Clinical Officer for AriBio, highlighted the significance of community physicians in the trial. "As we engage with interested investigators and sites across the world who are committed to making a difference in the treatment of patients with Alzheimer’s disease, we are pleased to have access to these community physicians who are on the front lines of patient care and often the first to see patients with early AD. These sites are paramount to running successful trials and providing access to diverse populations," said Rock.
About AR1001
AR1001 is under investigation for its potential to treat Alzheimer's disease. AriBio previously completed a Phase 2 study (NCT03625622) with AR1001 in a mild to moderate AD population in the US. The Phase 3 trial will further evaluate its therapeutic potential in early Alzheimer's disease.
