PTSD Study Uses Precision Medicine Tech from AiCure

AiCure, an AI and advanced data analytics provider, is working with the Defense Health Agency’s (DHA) PTSD Drug Treatment (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 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. Rich Christie, MD, PhD, Chief Medical Officer at AiCure, spoke to Medical Device & Technology about the program.

Rich Christie, MD, PhD

MDT: Can you provide the background on AiCure’s digital biomarker solution as a whole?

RC: During a clinical trial, a precise and accurate understanding of a patient’s response to treatment is critical to measure the state of their disease and a drug’s impact. Traditional means of measuring a patient’s well-being, including sporadic in-person assessments or a patient’s self-reported outcomes, only tell clinicians how a patient is feeling at that moment in time. The stretches between these check-ins can tell an entirely different story, filled with critical, subtle cues about their condition.

AiCure’s AI-powered digital biomarker solution enables remote detection of subtle changes in a patient’s health status and response to treatment by capturing audio and visual data between clinic visits. Accessed through AiCure’s Patient Connect application, patients use their smartphone’s front-facing camera to complete brief assessments. AiCure’s algorithm then analyzes behavior, such as emotional expressivity, physical movement and speech patterns. By frequently aggregating these sensitive, objective insights, AiCure empowers pharmaceutical companies to improve their understanding of the disease and treatment side effects, elevating the integrity of their trial data, and optimizing patient outcomes.

MDT: How does the technology work in the context of the DHA partnership?

RC: The DHA PTSD Drug Treatment Program is conducting an adaptive platform trial designed for the efficient and cost-effective testing of multiple PTSD treatments in both active service members and veterans. AiCure's medication adherence platform guides patients in their compliance to complex treatment regimens. The biomarker solution is described above, and the application features integrated built-in reminders and a communication system, allowing sites to contact the participant if they’ve missed a dose or check-in.

MDT: Can you describe the challenges of PTSD treatment?

RC: PTSD has a wide range of symptoms and has significant variation in how it presents across patients. Eighty percent of PTSD patients have at least one additional comorbidity such as depression, anxiety or substance abuse disorder, further complicating diagnosis and treatment. Despite the societal, financial, and emotional strain that PTSD exerts upon patients, there are only two FDA-approved therapies on the market.

The PTSD-DT Program's adaptive platform trial will evaluate the effect of therapeutics 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. The digital biomarker solution can be used to capture the subtle changes we discussed earlier, and may help investigators 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.

MDT: What does it involve in terms of patient interactions?

RC: Each time a patient doses in the trial, they will use the AiCure application. The smartphone-based application leverages computer vision and AI to remotely assess patient dosing behavior, ensuring the right patient ingested the right drug at the right time. This allows sites to monitor adherence and follow up with participants in instances of non-adherence. For the biomarker assessments, participants will be asked to perform simple tasks, such as describing images presented through the AiCure app in a few sentences to the camera of the smartphone, in order to record and analyze their responses.

MDT: How many patients will participate in the PTSD clinical trial?

RC: 450