India Globalization Capital (IGC) has begun a Phase II clinical trial of its drug candidate IGC-AD1 to treat agitation in dementia from Alzheimer’s Disease.

The multi-centre, randomised, double-blind, placebo-controlled trial will evaluate the efficacy and safety of the drug in these participants.

The Phase II trial has commenced at two sites in the US. The company plans to add between three to five more sites in Canada, the US, and possibly South America.

This addition is aimed at increasing population diversity, promoting underrepresented population inclusion, and helping IGC to better understand IGC-AD1’s impact on individuals of the Americas.

In the trial, 146 subjects will be enrolled with one half, the treated group, receiving IGC-AD1, and a placebo to be given to the other half, the control group.

The trial objective is to assess and establish IGC-AD1’s efficacy in helping Alzheimer’s dementia patients reduce neuropsychiatric symptoms (NPS) such as agitation, which affects 76% of individuals with Alzheimer’s.

At present, no Food and Drug Administration (FDA) approved drug is available to treat agitation in dementia related to Alzheimer’s.

IGC CEO Ram Mukunda said: “We believe that IGC-AD1 has the potential to revolutionise the treatment of Alzheimer’s Disease as the first, and only, low-dose natural THC-based formulation candidate currently undergoing FDA trials.

“We believe the diverse population we have selected for this study will allow us to accurately look at both the impact of variations of the gene CYP2C9 that metabolises THC, as well as APOE e4, a gene that increases the risk of developing Alzheimer’s.

“This data will help us to further understand the metabolism of IGC-AD1 for a diverse population, which is important in treating a disease that has a global impact like Alzheimer’s.”

IGC-AD1 depends on low THC doses and another compound as active agents in Alzheimer’s trials.