ClinicalTrials.gov Identifier: NCT05543681
| Attribute | Details |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting / Active |
| Sponsor | IGC Pharma |
| Intervention | IGC-AD1 (cannabinoid-based therapeutic) |
| Indication | Agitation in Alzheimer's Disease |
| Study Design | Parallel assignment |
IGC-AD1 is a cannabinoid-based therapeutic designed to modulate the endocannabinoid system to reduce agitation in Alzheimer's disease patients. The mechanism involves:
The endocannabinoid system plays a critical role in regulating emotional responses, anxiety, and behavioral symptoms. IGC-AD1 acts on:
Agitation is one of the most common and challenging behavioral and psychological symptoms of dementia (BPSD) in Alzheimer's disease, affecting up to 70% of patients during the disease course[3]. Current treatment options are limited:
Cannabinoid-based therapies offer a novel approach by:
As a Phase 1 trial, IGC-AD1 is primarily focused on:
Phase 1 trials typically evaluate:
IGC-AD1 enters a growing field of cannabinoid-based approaches for Alzheimer's agitation:
| Trial | Compound | Phase | Status |
|---|---|---|---|
| NAB-IT (NCT04516057) | Nabilone (synthetic THC) | Phase 3 | Recruiting |
| IGC-AD1 (NCT05543681) | IGC-AD1 | Phase 1 | Active |
| Various CBD trials | Cannabidiol | Phase 2/3 | Various |
IGC-AD1 represents a potentially novel cannabinoid formulation that may differ from existing synthetic cannabinoids like nabilone or dronabinol. The specific formulation may include multiple cannabinoid compounds rather than single-molecule approaches.
IGC Pharma is developing a portfolio of cannabinoid-based therapeutics:
Cannabinoid-based therapies have a generally favorable safety profile compared to antipsychotics, but monitoring is still essential:
The advantage of cannabinoids may include lower risk of the severe adverse effects associated with antipsychotics, particularly the increased mortality risk in elderly dementia patients. Additionally, the multi-target nature of cannabinoid compounds may address multiple aspects of Alzheimer's pathology beyond agitation.
Cannabinoid-based therapeutics face unique regulatory considerations:
The FDA has shown increasing openness to cannabinoid-based therapeutics, with several approvals in recent years for different indications. The successful development of IGC-AD1 could provide a much-needed alternative for treating agitation in Alzheimer's disease, a symptom that significantly impacts quality of life for both patients and caregivers.
Busquets-Garcia A, Puighermanal E, Pastor A, et al. Role of the endocannabinoid system in Alzheimer's disease: new perspectives. Life Sciences. 2014. ↩︎
Fernández-Ruiz J, Moro MA, Martínez-Orgado J. Cannabinoids in neurodegeneration and neuroprotection. Advances in Experimental Medicine and Biology. 2015. ↩︎
Cerejeira J, Lagarto L, Mukaetova-Ladinska EB. Behavioral and psychological symptoms of dementia. Frontiers in Neurology. 2012. ↩︎