IGC Pharma has announced the dosing of the first patient at ClinCloud, a new clinical research site in Florida, US, in its Phase IIb clinical trial of investigational therapy IGC-AD1 for Alzheimer's disease.
The trial underway is designed to assess the efficacy and safety of IGC-AD1 in managing agitation associated with Alzheimer's.
The company is currently advancing the trial across 12 locations in the US and Canada.
IGC Pharma is on track to expand its trial to further sites in these countries, aiming to enhance population diversity and include underrepresented groups.
The trial is set to enrol 146 participants, with 50% receiving IGC-AD1 and the other half receiving a placebo.
IGC-AD1 is a novel combination therapy that targets both neuroinflammation and agitation in Alzheimer's patients by acting as a cannabinoid receptor 1 (CB1) receptor partial agonist and an inhibitor of inflammasome.
Neurotransmitter imbalance, neuroinflammation, CB1 receptor loss and inflammasome-3 are claimed to be linked to agitation in dementia from Alzheimer's disease.
IGC Pharma CEO Ram Mukunda said: “This strategic expansion amplifies our reach and strengthens the depth of our data collection, marking a critical phase in our pursuit of an innovative therapy for agitation in Alzheimer’s disease.
“The expansion of our trial network underscores our commitment to a robust, scientifically driven approach, advancing our confidence in the potential of IGC-AD1.
“I am optimistic that our partnership with ClinCloud will bring us closer to developing an effective and safe therapy to address the global challenge of Alzheimer’s disease.”
ClinCloud, which has two facilities in Florida, one in Maitland and the other in Viera-Melbourne, is actively seeking individuals diagnosed with Alzheimer's and their caregivers for trial participation.
ClinCloud founder Jessica Branning said: “We are glad to support this Phase IIb clinical trial as it aligns with ClinCloud’s goal of transforming healthcare with continuous improvements and revolutionary breakthroughs.
“An oral solution with the ability to reduce agitation in Alzheimer’s would have a significant impact on patients’ quality of life.”
