IGC Starts Phase 2 Clinical Trials Of THC Based Drug Candidate For The Treatment Of Agitation In Dementia From Alzheimer's Disease

India Globalization Capital, Inc. IGC has begun “A phase 2, multi-center, double-blind, randomized, placebo-controlled, trial of the safety and efficacy of IGC-AD1 on agitation in participants with dementia due to Alzheimer’s disease”.

The company has commenced the Phase 2 study at two U.S. sites with plans to add between three to five additional sites in the United States, Canada, and possibly South America to increase population diversity, promoting both the inclusion of underrepresented populations and helping the company to better understand the impact of IGC-AD1 on the population of the Americas. The trial will enroll 146 patients with one half, the treated group, receiving IGC-AD1, and the other half, the control group, receiving a placebo. The goal of the trial is to evaluate and establish the efficacy of IGC-AD1 in helping patients with Alzheimer’s dementia reduce neuropsychiatric symptoms such as agitation, which affects 76% of individuals with Alzheimer’s (Mussele et al., 2015). Currently, there is no Food and Drug Administration approved drug for treating agitation in dementia related to Alzheimer’s (Jones et al., 2021).

“We believe that IGC-AD1 has the potential to revolutionize the treatment of Alzheimer’s disease as the first and only low-dose natural THC-based formulation candidate currently undergoing FDA trials,” stated Ram Mukunda, CEO of IGC. “Approximately 8 million people are affected by Alzheimer’s in North America and over 55 million worldwide. 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 metabolizes 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. Through these and further trials, we look forward to establishing IGC-AD1’s efficacy in treating the symptoms related to Alzheimer’s disease.”

IGC-AD1 relies on low-doses of THC, a psychoactive cannabinoid, and another compound as active agents in trials for Alzheimer’s. The formulation has recently completed phase 1 of clinical trials required by the FDA and demonstrated in Alzheimer’s cell lines the potential to be effective in suppressing or ameliorating a key protein that is responsible for Aβ plaques; a key hallmark of the disease.

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Photo by Jeff W on Unsplash

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