AiCure, an artificial intelligence (AI) and advanced data analytics company focused on improving clinical trials, today announced the DHA PTSD-DT Program will deploy AiCure’s AI platform in its post-traumatic stress disorder (PTSD) adaptive platform trial (APT) to simultaneously evaluate the efficacy of multiple PTSD treatments in both active service members and veterans. AiCure will work with the DHA PTSD-DT Program to deploy its medication adherence platform to guide patients in their compliance to complex treatment regimens, as well as its digital biomarker solution to unobtrusively capture the subtleties of a patient’s response. As PTSD has a wide range of symptoms, the trial aims to develop a precision medicine approach to prescribing the most effective therapy based on a patient’s unique biological and clinical characteristics. By optimizing personalized treatment matching, the PTSD-DT Program and AiCure aim to improve service members’ quality of life and maintain troop readiness, while also informing the development of future therapies.
There is significant variation in the presentation of PTSD across patients. Eighty percent have at least one additional comorbidity such as depression, anxiety or substance abuse disorder, complicating diagnosis and treatment further1. Despite the societal, financial, and emotional strain that PTSD exerts upon patients, treatment options remain scarce, with only two FDA approved therapies. To advance treatment options and patient care, the PTSD-DT Program’s APT will evaluate the effect of each therapy on a patient’s PTSD symptoms over 12 weeks. Because medication compliance has historically been a significant methodological problem in PTSD clinical trials, AiCure’s adherence platform will offer patients the necessary support to ensure correct dosing. AiCure’s digital biomarker solution will remotely detect subtle changes in a patient’s response to treatment by capturing and analyzing audio and video data, determining changes in emotional expressivity, physical movement, speech patterns and more. By frequently aggregating sensitive and objective insights and accurately measuring treatment adherence, AiCure may help identify the right drug for the right patient or allow clinicians to intervene in a patient’s treatment plan in a timely manner if the drug is not likely to be effective.
“Robust evidence for tailoring therapeutic interventions to individual patient needs remains the greatest unmet need in PTSD research today, but AI has the potential to propel precision medicine forward,” said Dr. Ed Ikeguchi, CEO of AiCure. “By achieving unimaginable levels of specificity when assessing a patient’s wellbeing, we can personalize their care and improve their quality of life. This innovative trial with the PTSD-DT Program illustrates our joint commitment to rewrite the script for PTSD care – a field that has remained largely stagnant for decades.”
Accelerating PTSD research through novel trial design
While most of these PTSD studies have historically assessed one drug at a time, the PTSD-DT Program will instead leverage an innovative trial design to simultaneously test multiple potential PTSD treatments through a multi-center, multi-arm randomized approach. With AiCure’s support, the trial will also uniquely interrogate the biological and environmental factors that underpin a treatment’s effectiveness, allowing for non-effective treatments to be identified more rapidly. While APTs have increasingly been used to address complex disorders in other disease areas, its use is novel in psychiatry.
“PTSD has plagued our service members for decades, and yet, available drug treatments are not as effective as we would like them to be. There’s an urgent need to improve unit readiness and lessen its detrimental impacts on our service members with PTSD, and developing targeted treatments will address this need,” said Dr. Kimberly del Carmen, the Product Manager at the U.S. Army Medical Materiel Development Activity (USAMMDA), who is managing the DHA PTSD-DT Program. “AiCure is a critical partner in this study as we aim to unlock the key to precision medicine in PTSD, understanding the nuances of a patient’s behavior, and in the future giving us the insights to proactively course-correct as needed.”
About AiCure, LLC
AiCure is an AI and advanced data analytics company that monitors patient behavior and enables remote patient engagement in clinical trials. AiCure improves predictability of study timelines, reduces costs and accelerates timelines through remote patient engagement and assessments, including measuring digital biomarkers and real-time monitoring of patient dosing. Founded in 2010 and funded by the National Institutes of Health (NIH) and leading institutional investors, AiCure has more than 75 issued patents and works with global clients in over 45 countries. AiCure is globally recognized and is a recipient of the Scrip Award, AI 100 and Digital Health 150. For more information, please visit www.aicure.com.
About US Army Medical Materiel Development Activity
The USAMMDA is a subordinate command of the U.S. Army Medical Research and Development Command, under the Army Futures Command. As the premier developer of world-class military medical capabilities, USAMMDA is responsible for developing and delivering critical products designed to protect and preserve the lives of Warfighters across the globe. These products include drugs, vaccines, biologics, devices and medical support equipment intended to maximize survival of casualties on the battlefield.
About Defense Health Agency
The Defense Health Agency is a joint, strategic Combat Support Agency that enables uniformed medical services to provide a medically ready force and ready medical force to Combatant Commands in both peacetime and wartime. DHA supports the National Defense Strategy and Service Military Departments by leading the Military Health System as an integrated, highly-reliable system of readiness, medical training, and health. DHA leads a research and acquisitions enterprise to shepherd innovative materiel and knowledge products, from concept through final product development and sustainment, into the hands of providers and warfighters.
1 American Family Physician. Diagnosis and Management of Post-Traumatic Stress Disorder. https://www.aafp.org/afp/2003/1215/p2401.html