IGC Pharma, Inc. 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 (clinicaltrials.gov, Identifier: CT05543681). The secondary outcome, as measured by the change in agitation versus placebo using a standard measurement scale, the Cohen Mansfield Agitation Inventory (?CMAI?) at baseline and week 2, exhibited an Effect Size (?ES?) of 0.79 (p=0.071) indicating a large magnitude of difference between the active and placebo groups. For context, a study published in 2003 concluded that an effect size over 0.5 corresponds to a change that is noticeable to a careful observer, highlighting the notable impact of IGC-AD1.

Further, in May 2023, the FDA approved Brexpiprazole, an atypical antipsychotic, with a boxed warning. This approval followed a significantly larger 12-week Phase 3 trial, which showed a Cohen?s d effect size of 0.35 whereas IGC-AD1 showed an effect size of 0.79 in two weeks, emphasizing, subject to further trials, the potential of IGC-AD1 as a treatment option. 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.