IGC Pharma, Inc. (NYSE American:IGC) has announced that its Phase 2 clinical trial for agitation in Alzheimer's disease is now officially named CALMA (Calming Agitation in Alzheimer's). This trial aims to address agitation, a common and distressing syndrome affecting a significant portion of Alzheimer's patients worldwide.
The CALMA trial is designed to evaluate the safety and efficacy of IGC-AD1, a partial CB1 receptor agonist with anti-neuroinflammatory properties, for treating agitation in Alzheimer's patients. Agitation accelerates cognitive decline and increases hospitalization rates, making it a critical target for therapeutic intervention.
Innovative Recruitment Strategy
To accelerate enrollment across clinical sites in the USA and Canada, IGC Pharma has implemented an innovative recruitment campaign. This strategy leverages geofencing technology and digital outreach through social media platforms to target potential participants within a 15-25 mile radius of trial sites.
According to Ram Mukunda, CEO of IGC Pharma, this approach has already yielded impressive results. "Recruitment is one of the most significant challenges in Alzheimer's clinical trials," Mukunda stated. "Our use of innovative geofencing technology... has delivered impressive results, achieving a significant outreach and enrollment at select sites."
Trial Design and Objectives
The CALMA trial is a multicenter, double-blind, randomized, placebo-controlled Phase 2 study involving 164 participants. The primary objective is to assess the impact of IGC-AD1 on agitation in Alzheimer's patients. Secondary endpoints include evaluating the drug's effects on cognitive function and overall quality of life.
IGC-AD1, the investigational drug in the CALMA trial, is a cannabinoid-based treatment. Interim data suggests it offers faster-acting and more effective relief compared to traditional medications for agitation in dementia.
Addressing a Critical Unmet Need
Agitation affects up to 76% of the 55 million Alzheimer's patients worldwide, significantly impacting both patients and their caregivers. The CALMA trial represents a crucial step forward in creating value for both patients and shareholders by addressing this unmet need.
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. The company anticipates completing enrollment and the CALMA trial in the second half of 2025.
