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IGC Pharma, Inc, an AI-powered, clinical-stage biotechnology company focused on developing innovative treatments for Alzheimer’s disease and transforming patient care with fast-acting, safe, and effective solutions, has announced that its ongoing phase 2 clinical trial for agitation in Alzheimer’s disease has been officially named CALMA (Calming Agitation in Alzheimer’s).
The trial’s new identity reflects its mission to address agitation, a syndrome affecting up to 76 per cent of the 55 million Alzheimer’s patients worldwide that also adversely impacts the quality of life for both patients and their caregivers.
To accelerate enrollment across all clinical sites, IGC Pharma has implemented an innovative recruitment campaign leveraging geofencing technology and digital outreach through social media platforms. The recruitment strategy was piloted at select trial sites, where it achieved a remarkable 200-300% increase in enrollment at a relatively low cost per lead. Building on this success, IGC Pharma is expanding the campaign to the other trial locations, with the goal of completing enrollment and the CALMA trial in the second half of 2025.
By combining advanced outreach tools with CALMA’s clear focus, IGC aims to enhance engagement with patients and caregivers while advancing toward key milestones in Alzheimer’s treatment development.
Ram Mukunda, CEO of IGC Pharma, commented, “Recruitment is one of the most significant challenges in Alzheimer’s clinical trials, and our use of innovative geofencing technology, wherein we digitally target individuals living in a 15-25-mile radius of a clinical site, has delivered impressive results, achieving a significant outreach and enrollment at select sites. Scaling this strategy across all trial locations, in the USA and Canada, we expect will accelerate our progress toward completing the CALMA trial and strengthen our ability to engage with patients and caregivers. The strategy is especially powerful in recruiting members of underserved communities. By leveraging advanced digital outreach tools, we aim to enhance trial awareness, streamline recruitment, and advance IGC-AD1’s development as a transformative therapy for Alzheimer’s agitation. This milestone represents another step forward in creating value for both patients and our shareholders.”
The CALMA trial is a multicenter, double-blind, randomized, placebo-controlled phase 2 study involving 164 participants. It is designed to evaluate the safety and efficacy of IGC-AD1, a partial CB1 receptor agonist with anti-neuroinflammatory properties, in treating agitation - a syndrome that accelerates cognitive decline and increases hospitalization rates among Alzheimer’s patients.
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