IGC Pharma: Trial data show reduction in Alzheimer’s agitation at week two

IGC Pharma announced that interim data from its Phase 2 clinical trial demonstrates a clinically significant reduction, approaching statistical significance, in agitation in Alzheimer’s at week two compared to placebo. IGC-AD1 targets neuroinflammation and CB1 receptor dysfunction, and the investigational drug contains THC as one of two active pharmaceutical agents. THC is a principal psychoactive cannabinoid found in Cannabis. IGC-AD1 is a first-of-its-kind THC-based-formulation undergoing a formal Phase 2 clinical trial in Alzheimer’s disease. “We are excited to share that the interim results on the secondary outcome show that IGC-AD1 can provide fast relief with few side effects in reducing agitation in Alzheimer’s dementia compared to placebo. We are especially excited by these results given the limited therapeutic options currently available,” said Ram Mukunda, CEO of IGC Pharma…The secondary outcome, as measured by the change in agitation versus placebo using a standard measurement scale, the Cohen Mansfield Agitation Inventory or CMAI at baseline and week 2, exhibited an The ongoing 146-patient clinical trial is a multicenter, double-blind, randomized, placebo-controlled study designed to assess safety and efficacy of IGC-AD1 in treating agitation in dementia due to Alzheimer’s. To date over 1,000 oral doses have been administered, with no dose-limiting adverse events observed, highlighting the safety profile of IGC-AD1.