Interim Analysis Reveals Statistically Significant Reduction in Agitation Levels
IGC Pharma (IGC) has unveiled encouraging findings from its ongoing Phase 2 trial of IGC-AD1 for Agitation in Dementia from Alzheimer’s Disease (AAD). With Alzheimer’s affecting an estimated 6.7 million Americans in 2023, addressing agitation is crucial, as up to 76% of patients experience this symptom.
The interim analysis showcases a notable reduction in agitation among Alzheimer’s patients treated with IGC-AD1 compared to those receiving a placebo. Using the Cohen Mansfield Agitation Inventory (CMAI) scale, patients exhibited significantly lower agitation scores as early as week two of the trial.
Key findings include a Cohen’s d effect size of 0.66 at the primary outcome assessment at week six, indicating the superiority of IGC-AD1 over placebo. Additionally, the LS mean difference between active and placebo was -10.45, with a p-value of 0.037.
These promising results underscore the potential of IGC-AD1 to improve patient outcomes in Alzheimer’s-related agitation. Ram Mukunda, CEO of IGC Pharma, expressed confidence in the clinical profile of IGC-AD1, signaling its potential to drive shareholder value pending further trials.
Read original press release:here
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