IGC Pharma has announced promising interim results from its ongoing Phase 2 clinical trial of IGC-AD1, showing significant improvements in sleep disturbances among Alzheimer's disease patients. The cannabinoid-based investigational treatment demonstrated a 71% reduction in sleep disturbances at week 2 (p=.012) and a 78% reduction at week 6 (p=.02) compared to placebo.
The data, measured using the Neuropsychiatric Inventory (NPI-12) Sleep Subscale, indicates both clinical and statistical significance in addressing sleep problems that affect up to 44% of Alzheimer's patients. Sleep disturbances represent an underrecognized yet critical challenge in Alzheimer's care, impacting both patients and caregivers.
"IGC-AD1's ability to improve sleep quality in Alzheimer's patients is very exciting," said Ram Mukunda, CEO of IGC Pharma. "Better sleep is linked to reduced agitation and caregiver distress, as well as slowing cognitive decline and improving overall quality of life."
Mechanism of Action and Potential Advantages
IGC-AD1 functions as a partial CB1 receptor agonist with anti-neuroinflammatory and neuroprotective properties. Unlike conventional sedatives that primarily mask symptoms, IGC-AD1 may offer a more targeted approach to sleep regulation in Alzheimer's disease.
Current treatment options for sleep disturbances in Alzheimer's patients, including Trazodone and Suvorexant, have shown limited efficacy in placebo-controlled trials with dementia patients. IGC-AD1's differentiated mechanism potentially offers a safer and more effective alternative, though larger trials will be needed to confirm these early findings.
Research has established connections between improved sleep quality and reduced amyloid accumulation, potentially slowing disease progression. Previously reported data from the same trial also showed notable reductions in agitation, suggesting IGC-AD1 may function as a multi-targeted therapy for addressing various neuropsychiatric symptoms in Alzheimer's patients.
Market Potential and Future Directions
Beyond Alzheimer's disease, sleep disorders affect over 30 million Americans and are recognized risk factors for cognitive decline and cardiovascular disease. The global sleep aid market is projected to exceed $100 billion by 2030, representing a significant commercial opportunity for innovative therapies like IGC-AD1, pending verification through larger clinical trials.
IGC Pharma is continuing its Phase 2 trial of IGC-AD1, recently named CALMA, with further analysis expected by the end of 2025. The company also plans to launch additional studies evaluating IGC-AD1 as a potential disease-modifying treatment for Alzheimer's disease.
About IGC Pharma
IGC Pharma (NYSE American: IGC) is a clinical-stage biotechnology company leveraging artificial intelligence to develop innovative treatments for Alzheimer's and metabolic disorders. Beyond IGC-AD1, the company's pipeline includes TGR-63, which targets amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions.
The company integrates AI technology to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With 55 patent filings, IGC Pharma demonstrates a commitment to innovation in developing breakthrough therapies. The company also operates Holiby™, a wellness brand offering scientifically formulated products for immunity, energy, and longevity.
For more information about the ongoing clinical trial, interested parties can visit clinicaltrials.gov.
