IGC Pharma, Inc. announced the addition of an important trial site at the University of Puerto Rico network as an expansion of the Company?s ongoing Phase 2 clinical trial investigating lead drug asset, IGC-AD1, as a treatment for lowering agitation in patients with Alzheimer?s disease. IGC-AD1 is the only natural THC-based investigational drug undergoing FDA trials. The therapy relies on low doses of THC and another compound as pharmaceutical active agents for the treatment of Alzheimer?s disease and has shown in pre-clinical studies the potential to be effective in ameliorating Aß plaques and in Phase 1 the potential to reduce neuropsychiatric symptoms such as agitation in dementia due to Alzheimer?s. The expansion of the Phase 2 trial into Puerto Rico aims to increase population diversity and promote the inclusion of underrepresented populations.

The Company plans to further increase population diversity by adding future sites in South America and Canada. The trial will enroll 146 patients with one half, the treated group, receiving IGC-AD1, and the other half, the control group, receiving a placebo. The goal of the trial is to evaluate and establish the efficacy of IGC-AD1 in helping patients with Alzheimer?s dementia reduce neuropsychiatric symptoms (?NPS?) such as agitation, which affects 76% of individuals with Alzheimer?s (Mussele et al., 2015).