The company has just announced the results of an interim analysis of its ongoing phase 2 trial. The main objective of the study is to evaluate the change in AAD over six weeks, utilizing the Cohen Mansfield Agitation Inventory (CMAI). The study showed that patients who were given IGC-AD1 had a more significant reduction in agitation levels compared to those who were given a placebo, with positive effects being observed as early as week two of the trial. 

At the six-week mark, the difference in agitation levels between the IGC-AD1 group and the placebo group was quite noticeable, with an effect size of 0.66 according to Cohen’s d measure. The mean difference in the CMAI scores between the active treatment and placebo was -10.45, which indicates a meaningful contrast. Additionally, at the two-week mark, a secondary evaluation showed a positive effect size of 0.79 for IGC-AD1 compared to the placebo. 

“We are excited with the positive interim results from the Phase 2 trial of IGC-AD1 for agitation in dementia due to Alzheimer’s disease. IGC-AD1’s interim results demonstrate a clinical and statistically significant reduction in agitation compared to placebo, suggesting a strong plausibility to address a substantial unmet medical need. This interim data validates IGC-AD1’s potential as a transformative therapeutic option with a large market opportunity in Alzheimer’s disease management,” said Ram Mukunda, CEO of IGC Pharma.