Interim trial results show THC-based treatment reduces agitation in Alzheimer’s disease

IGC Pharma has announced positive interim results from an ongoing phase 2 trial investigating IGC-AD1, a natural THC-based oral formulation, as a treatment for agitation in dementia from Alzheimer’s disease.

According to a company press release, IGC-AD1 demonstrated a clinical and statistically significant reduction in agitation compared with placebo in patients with AD, with positive effects reported as early as week 2 of the trial.

The multicenter, randomized, double-blind trial is designed to assess change in agitation after 6 weeks, based on the Cohen Mansfield Agitation Inventory (CMAI) scale, with ratings taken at baseline and weeks 2 and 6. Participants received IGC-AD1 1 mL or placebo twice daily for 6 weeks.

According to the release, the least square mean CMAI score difference at week 6 between treatment and placebo groups was –10.45, with Cohen’s d effect size of 0.79 and 0.66, respectively, at weeks 2 and 6.

“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,” CEO Ram Mukunda said in the release. “With IGC-AD1’s promising clinical profile, we are confident in its ability, subject to further trials, to improve patient outcomes.”