IGC Pharma Adds Brooklyn Site to Boost AI‑Enhanced Alzheimer’s Agitation Trial

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IGC Pharma Expands Alzheimer’s Trial Network With Integrative Clinical Trials Addition

IGC Pharma Inc. Has Strengthened Its Clinical Trial Network For IGC-AD1, A Novel Therapy Aimed At Treating Agitation associated With Alzheimer’s Disease, Through A New Collaboration With Integrative Clinical Trials. The Partnership Bolsters Expertise In Central Nervous System (CNS) Disorders, Positioning The Company For Efficient Trial Execution And High-Quality Data Generation.

Expanding Capacity For Alzheimer’s Research

The Addition Of Integrative Clinical Trials Represents A Strategic Expansion Of IGC pharma’s Clinical Infrastructure.The Site Brings To The Table A Deep Bench Of Experience In Neuropsychiatric And Neurodegenerative Disease Research. This expertise Is Crucial As IGC Pharma Advances Its Phase II Trial Of IGC-AD1.

In 2024, IGC Pharma Began enrolling Patients At Neurostudies, A Clinical Research Site Located In Port Charlotte, Florida, For The IGC-AD1 Trial. The Trial Focuses On Addressing Agitation, A Common And Debilitating Symptom Of Alzheimer’s Disease, Affecting Millions Globally. The Alzheimer’s Association Reports That More Than 6.7 Million Americans Are Living With Alzheimer’s Disease As Of 2023.

IGC-AD1: A Promising Therapeutic Approach

IGC-AD1 Is Being Developed As A Potential Treatment To Manage Agitation In Alzheimer’s Patients. Agitation Can Manifest As restlessness, Verbal Aggression, And Physical Violence, Significantly Impacting Both Patients And caregivers. Current Treatments Frequently enough Have Limited Effectiveness And Can Carry Notable Side Effects.

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What benefits does the addition of the new Brooklyn site bring to IGC Pharma’s Alzheimer’s agitation trial?

IGC Pharma Expands Alzheimer’s Agitation Trial with New Brooklyn Site

IGC Pharma, Inc. is strategically bolstering its phase 2 clinical trial evaluating IGC-AD1, an innovative drug candidate for the treatment of agitation in Alzheimer’s disease, with the addition of a new clinical site in Brooklyn, New york. This expansion signifies a crucial step forward in the company’s efforts to address a significant unmet need in Alzheimer’s care – managing behavioral and psychological symptoms of dementia (BPSD).

expanding Access and Accelerating Enrollment

The Brooklyn site, operated by experienced neurology research professionals, will significantly broaden patient access to the trial. Agitation is a particularly challenging symptom for both patients and caregivers, frequently enough leading to hospitalization and reduced quality of life. Increasing the number of trial locations is a direct response to the demand for potential new treatment options and aims to accelerate patient enrollment.

* Increased Patient Pool: The new site taps into a larger, more diverse patient population within the New York metropolitan area.

* Faster Enrollment: Multiple sites streamline the recruitment process,potentially shortening the overall trial timeline.

* Geographic Diversity: Expanding geographically helps ensure the trial results are representative of the broader Alzheimer’s patient community.

AI-Powered Precision in Alzheimer’s research

What sets this trial apart is IGC Pharma’s integration of Artificial Intelligence (AI) throughout the study. the company is utilizing AI-driven tools to:

1. optimize Patient Selection: AI algorithms analyze patient data to identify individuals most likely to respond to IGC-AD1, improving the efficiency and effectiveness of the trial.
2. Enhance Data Analysis: AI is employed to analyze complex datasets generated during the trial, identifying subtle patterns and correlations that might be missed by conventional statistical methods. This includes analyzing behavioral data collected through wearable sensors and digital diaries.
3. personalized Treatment Approaches: the ultimate goal is to leverage AI to personalize treatment strategies for Alzheimer’s agitation, tailoring interventions to individual patient needs.

Understanding IGC-AD1: A Novel Approach

IGC-AD1 is a novel, proprietary formulation of palmitoylethanolamide (PEA), a naturally occurring fatty acid amide. Preclinical studies have demonstrated IGC-AD1’s potential to modulate the brain’s inflammatory response and restore neuronal function. Unlike many current treatments for agitation, which often carry significant side effects, IGC-AD1 is designed to be well-tolerated.

* Mechanism of Action: IGC-AD1 targets neuroinflammation, a key driver of Alzheimer’s disease progression and agitation.

* Safety Profile: Early data suggests a favorable safety profile, making it a potentially viable long-term treatment option.

* Targeted Therapy: The focus on neuroinflammation represents a shift towards more targeted therapies for Alzheimer’s disease.

The challenge of alzheimer’s Agitation

Alzheimer’s agitation encompasses a range of behaviors, including restlessness, pacing, verbal aggression, and physical outbursts. It affects a considerable proportion of individuals with Alzheimer’s, particularly in the moderate to severe stages of the disease.

* Prevalence: An estimated 50-70% of Alzheimer’s patients experience significant agitation.

* Caregiver Burden: Agitation places a tremendous burden on caregivers, often leading to burnout and reduced quality of life.

* Healthcare Costs: Managing agitation is a significant driver of healthcare costs, due to frequent hospitalizations and emergency room visits.

trial Details and Enrollment Information

The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of IGC-AD1 in patients with mild to moderate Alzheimer’s disease experiencing agitation.

* Study Design: Randomized, double-blind, placebo-controlled.

* Patient Population: Individuals with mild to moderate Alzheimer’s disease and clinically significant agitation.

* Primary Endpoint: Change from baseline in a standardized agitation rating scale.

* Enrollment: Interested individuals and their caregivers can find more information about the trial, including eligibility criteria and contact details, on the IGC Pharma website and ClinicalTrials.gov (identifier available on the IGC Pharma website).

The Future of Alzheimer’s treatment

IGC Pharma’s commitment to leveraging AI and exploring novel therapeutic approaches like IGC-AD1 represents a promising direction for Alzheimer’s research. The addition of the Brooklyn site is a tangible exhibition of the company’s dedication to bringing innovative solutions to patients and families affected by this devastating disease. The ongoing trial will provide critical data to determine the potential of IGC-AD1 to improve the lives of those living with Alzheimer’s agitation.