IGC-AD1 Shows Promise for Alzheimer’s-Related Agitation in Phase II Trial

IGC Pharma’s Phase II CALMA trial (NCT05543681) of IGC-AD1, a cannabinoid-based partial CB1 receptor agonist, has shown encouraging interim results for agitation in dementia related to Alzheimer’s disease.

Key Findings:

• 71% reduction in sleep disturbances by week 2, increasing to 78% by week 6.
• Results measured using the Neuropsychiatric Inventory (NPI-12) Sleep Subscale.
• Targeting neuroinflammation, IGC-AD1 aims to improve sleep disturbances and nighttime behaviors.

Market & Competition:

• Alzheimer’s sleep disturbances affect up to 50% of moderate-to-severe cases (Mayo Clinic).
• 829 therapies in development for agitation in Alzheimer’s dementia (GlobalData).
• Market projected to grow from $2.8B (2024) to $4.9B by 2030.
• Otsuka Holdings’ Rexulti dominates with $1.8B in 2024 sales.

The update precedes the 2025 AD/PD Conference, where Alzheimer’s research advancements will be discussed.

31-03-2025

• Pharma GMP
• Food GMP
• Clinical Research
• Medical Device
• Environmental Health and Safety
• Healthcare
• Nutrition