IGC Pharma Adds Visionary Investigators Network as Clinical Site to Phase 2 CALMA Trial
IGC Pharma has added Visionary Investigators Network as a clinical site to its Phase 2 CALMA trial, which is evaluating a cannabinoid-based therapy for the management of agitation in Alzheimer’s disease. Expansion of enrollment sites is a standard step in Phase 2 trials to improve recruitment and support the generation of rigorous efficacy and safety data.
Why this matters
Agitation in Alzheimer’s disease remains difficult to manage, with current pharmacologic options carrying significant safety burdens, including black box warnings for antipsychotics in elderly dementia patients. Expansion of the CALMA Phase 2 trial to additional clinical sites increases enrollment capacity and geographic diversity, which strengthens the statistical power and generalizability of findings on cannabinoid-based intervention for this indication. Rigorous randomized controlled data on cannabinoid therapy in this population would directly inform prescribing decisions where evidence-based alternatives are urgently needed.
Dr. Caplan take
“Expanding clinical sites in a Phase 2 trial like CALMA is exactly how we move cannabinoid medicine out of anecdote and into evidence, and for a population as vulnerable as Alzheimer’s patients with refractory agitation, that rigor isn’t optional. I’ve watched families cycle through off-label antipsychotics with serious adverse effect profiles while cannabinoid options sit underutilized simply because we lack the trial data to support confident prescribing. This kind of infrastructure growth is what closes that gap.”
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