IGC Pharma Begins Patient Enrollment for Phase 2 Alzheimer’s Agitation Trial at Neurostudies
IGC Pharma has commenced patient enrollment at Neurostudies, Inc. in Port Charlotte, Florida, for its Phase 2 clinical trial investigating IGC-AD1 as a potential treatment for agitation in Alzheimer’s disease.
IGC-AD1 is a partial CB1r agonist with anti-neuroinflammatory properties and an inflammasome inhibitor, designed to treat agitation in dementia caused by Alzheimer’s disease. This formulation includes low doses of Tetrahydrocannabinol (THC), the principal psychoactive cannabinoid in cannabis, making it the first THC-based formulation to undergo a formal Phase 2 clinical trial for Alzheimer’s disease.
Neurostudies, led by Principal Investigator Dr. Liliana Montoya and Sub-Investigator Dr. George Li, has over 20 years of clinical research experience. The enrollment of the first two patients on May 1 and May 24, 2024, marks a significant milestone in IGC Pharma’s efforts to develop innovative therapies for Alzheimer’s-related agitation.
Ram Mukunda, CEO of IGC Pharma, emphasized, “Today’s announcement signifies another step forward in our mission to bring IGC-AD1 to market as a therapy for agitation in Alzheimer’s dementia. Patient enrollment at Neurostudies highlights our strategic approach to clinical development and our dedication to enhancing shareholder value through scientific innovation. We are confident that our innovative approach, combined with the expertise of Dr. Montoya and Dr. Li, will drive transformative advancements in Alzheimer’s care.”
Dr. Liliana Montoya added, “Agitation is a major challenge for patients with Alzheimer’s and their families. Leading this Phase 2 trial at Neurostudies underscores our commitment to rigorous scientific inquiry and improving patient care. Our collaboration with IGC Pharma offers a chance to translate scientific innovation into tangible benefits for those affected by Alzheimer’s.”
IGC Pharma plans to expand its trial network to include 11 additional sites in the U.S. and Canada, aiming to enroll 146 patients, with half receiving the active medication and the other half receiving a placebo.
IGC Pharma Inc. focuses on developing innovative treatments for Alzheimer’s disease, with a robust pipeline of five promising drug candidates. These include IGC-AD1, which targets neuroinflammation and other hallmarks of Alzheimer’s, and is currently in Phase 2 trials for agitation in Alzheimer’s dementia. Other candidates like TGR-63, IGC-M3, and IGC-1C are in various stages of development, targeting Aβ plaques and tau protein. Additionally, IGC Pharma leverages artificial intelligence for Alzheimer’s research, including clinical trial optimization and early detection initiatives.
