IGC Pharma has expanded its CALMA Phase II clinical trial by adding Integrative Clinical Trials, based in Brooklyn, New York, US, as a new site evaluating IGC-AD1 for agitation associated with Alzheimer’s disease.
Integrative Clinical Trials conducts studies across a broad range of central nervous system (CNS) disorders, including mild cognitive impairment and Alzheimer’s.
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The site is led by principal investigator Dr Inna Yuryev-Golger, who has more than ten years of experience in clinical research, and Bella Yevseva, who serves as clinical trial coordinator.
The centre enhances IGC Pharma’s access to a diverse patient population in a major metropolitan area. The company stated that bringing in sites with CNS experience is central to supporting enrolment and patient engagement for the ongoing study.
IGC-AD1 is an investigational cannabinoid-based therapy being studied in a double-blind, placebo-controlled, randomised Phase II clinical trial for patients experiencing agitation related to Alzheimer’s.
The ongoing expansion of the CALMA trial demonstrates IGC Pharma’s efforts to facilitate patient enrolment and ensure comprehensive clinical monitoring during the study.
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By GlobalDataIGC develops therapies for Alzheimer’s and metabolic disorders using AI. Its pipeline includes TGR-63 (targeting amyloid plaques), IGC-AD1, and additional early-stage programmes focused on tau proteins, metabolic dysfunctions, and neurodegeneration.
IGC CEO Ram Mukunda said: “Adding Integrative Clinical Trials further strengthens our CALMA clinical network with a site that has deep expertise across CNS disorders.
“Their experience in neuropsychiatric and neurodegenerative research supports our commitment to high-quality data generation and efficient trial execution as we advance IGC-AD1.”
In 2024, IGC Pharma reported the enrolment of two subjects at Neurostudies, a clinical research site in Port Charlotte, Florida, US, for its Phase II trial of IGC-AD1 to treat agitation in Alzheimer’s.