Adaptive Research Announces it has Begun Enrolling Patients in AriBio’s Phase 3 POLARIS-AD Clinical Trial
SAN FRANCISCO, Sept. 30, 2024 (GLOBE NEWSWIRE) — Adaptive Research, a clinical trial site organization whose mission is to democratize clinical trials by providing full-service support to trial investigators in community settings, announced two community practices that are part of the Adaptive Research network have begun patient enrollment and randomization in AriBio’s 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). Noor Sachdev, MD and Perminder Bhatia, MD will serve as investigators with regulatory, finance, and clinical support for all study-related activities provided by Adaptive Research.
“Studies such as this—which require participants to have signs and symptoms associated with the early stage of Alzheimer’s, such as some memory, planning, and organizational issues, and have a care partner who can accompany them to study visits—demonstrate the value of including community sites,” said Deepak Behera, MD, President and Chief Executive Officer of Adaptive Research. “Travel time to academic settings can contribute to inequalities in Alzheimer’s disease clinical trial enrollment due to age, geography, and ethnicity. 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.”
“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 James Rock, Chief Clinical Officer for AriBio.
AriBio previously completed a Phase 2 study (NCT03625622) with AR1001 in a mild to moderate AD population in the US. AriBio is expected to enroll 1150 participants in this global Phase 3 clinical trial to evaluate the therapeutic potential of AR1001 in the treatment of early Alzheimer’s disease.
About AR1001
About AR1001-ADP3-US01
AR1001-ADP3-US01 (NCT05531526) is 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. The study aims to assess the efficacy and safety of AR1001 in slowing the progression of Alzheimer’s disease through various cognitive and functional assessments. The details of the clinical trial are available at ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT05531526).
About Adaptive Research
Founded in 2020, Adaptive Research Inc. is revolutionizing the landscape of clinical trials. By offering full-service support to trial investigators, Adaptive Research connects Sponsors of potential life-saving investigational agents and medical devices with community physicians and their patients nationwide. Adaptive Research’s expert team functions as a virtual clinical trials office, managing administrative and regulatory responsibilities, and enabling physicians to focus on their paramount task: providing exceptional clinical judgement and care. For additional information, visit https://adaptiveresearch.com.
About AriBio
AriBio Co., Ltd. is a biopharmaceutical company based in South Korea with offices in the United States. The company focuses on the development of novel therapies for neurodegenerative diseases including Alzheimer’s disease.
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