On August 25, 2025, IGC Pharma, Inc. announced the expansion of its Phase 2 CALMA clinical trial, a study focused on testing the effectiveness of its investigational compound IGC-AD1 in treating agitation among patients with Alzheimer’s disease. The company revealed that a new trial site has been added at the Lynn Health Science Institute in Oklahoma City, with enrollment now underway under the supervision of Dr. Carl Griffin, MD. The inclusion of this additional location is part of a broader strategy to strengthen recruitment, expand patient access, and increase the diversity of the participant pool.
The CALMA trial, whose name reflects its focus on calming agitation in Alzheimer’s patients, is designed as a multicenter, randomized, double-blind, placebo-controlled study. It is currently testing IGC-AD1, a cannabinoid-based investigational therapy believed to work through partial activation of CB1 receptors and anti-inflammatory pathways in the brain. Researchers hope that the compound can help alleviate one of the most difficult behavioral symptoms of Alzheimer’s disease—agitation—which frequently places a heavy burden on patients, caregivers, and long-term care systems.
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The addition of the Lynn Health Science Institute to the list of participating sites underscores IGC Pharma’s commitment to making the trial more geographically inclusive. By adding locations across multiple states and now extending into Canada, the company is ensuring that people from different regions, backgrounds, and demographics have a chance to participate. Alzheimer’s disease affects more than six million Americans, and agitation is one of the most common and distressing symptoms, often leading to emergency medical interventions, earlier nursing home placement, and significant caregiver stress. The expansion is expected to help collect more robust data that better reflects real-world patient experiences.
Throughout 2025, IGC Pharma has been steadily growing the CALMA trial. Earlier in the year, the company announced new partnerships with sites such as the MIND Institute at Miami Jewish Health in Florida and Butler Hospital’s Memory and Aging Program in Rhode Island. It also partnered with Hamilton Health Sciences in Ontario, Canada, marking its first expansion beyond the United States. In June, Tekton Research in Yukon, Oklahoma joined the trial, providing a strong presence in the central U.S. With the latest addition of the Lynn Health Science Institute, Oklahoma now plays a key role in advancing the study.
One of the central challenges in Alzheimer’s research has been patient recruitment. Clinical trials often struggle to enroll enough participants within their planned timelines, which can delay the development of promising therapies. IGC Pharma has addressed this issue by employing innovative recruitment strategies, including digital outreach and geofencing. These tools have already boosted enrollment rates by as much as 200 to 300 percent at some sites, according to company updates earlier this year. By rolling out these approaches across all trial locations, IGC hopes to accelerate the study’s progress and move closer to generating the data required for regulatory consideration.
For families living with Alzheimer’s, agitation presents daily challenges. It is characterized by restlessness, verbal outbursts, aggression, and heightened anxiety, behaviors that can be overwhelming for caregivers and dangerous for patients. Existing treatment options are limited, often relying on antipsychotic medications that come with significant side effects and limited long-term effectiveness. A safer, targeted therapy for agitation would represent a major advancement in Alzheimer’s care, improving the quality of life not only for patients but also for the millions of family members and caregivers who support them.
The Phase 2 CALMA trial is designed to evaluate both the safety and effectiveness of IGC-AD1 in a carefully monitored environment. By testing the compound across diverse populations and locations, the company hopes to ensure that results are broadly applicable. Success in this mid-stage trial could pave the way for a larger Phase 3 study, which would be the final step before seeking regulatory approval. While the road to market is lengthy and rigorous, each site expansion represents meaningful progress toward a potential new treatment option.
The addition of the Lynn Health Science Institute reflects the momentum behind the CALMA trial and highlights the increasing collaboration between academic centers, private research institutes, and pharmaceutical developers. As Alzheimer’s continues to rise in prevalence with the aging population, there is mounting urgency to develop better treatments not only for cognitive decline but also for the behavioral and psychological symptoms that accompany the disease. IGC Pharma’s ongoing expansion signals that the company is prepared to meet that challenge head-on.
If successful, IGC-AD1 could emerge as one of the first therapies specifically aimed at treating agitation in Alzheimer’s, filling a critical gap in care. For now, the expansion of the trial to Oklahoma City offers new hope to patients and families in the region while strengthening the study’s ability to deliver meaningful scientific results.
