The promise of

IGC-AD1

Findings from phase 1 study suggest that IGC-AD1 has the potential to safely reduce the debilitating symptoms affecting millions of Alzheimer’s patients.

IGC-AD1 is designed to target neuroinflammation, potentially stabilize CB1r function and address neurotransmitter imbalances, all hallmarks associated with agitation in Alzheimer’s Dementia.

Phase 1 and Phase 2 trials are registered on clinicaltrials.gov

IGC-AD1 Timeline

2017

IGC Pharma begins development of the IGC-AD1 oral formulation.

2019

IGC-AD1 is approved by the FDA as an investigational new drug.

2021

Phase 1 clinical trial testing safety and tolerability in humans with Alzheimer’s successfully completed.

IGC-AD1 is awarded patent protection in the U.S.

2022

Phase 2 clinical trial to evaluate the efficacy of IGC-AD1 begins.

Additional patent awarded protecting IGC-AD1 formulation.

2023

IGC-AD1 is a awarded patent protection in Mexico

2024

Positive interim analysis of Its ongoing Phase 2 Trial

Why IGC-AD1 & Agitation in Alzheimer’s Dementia?

The endocannabinoid system has been a target of interest for agitation in AD due to its potential impact on mechanisms implicated in AD such as oxidative stress and neuroinflammation.

The APIs in IGC-AD1 have been associated with inhibiting inflammatory and oxidative stress markers associated with agitation in Alzheimer’s¹.

The APIs in IGC-AD1 are proposed to reduce agitation by regulating impaired neurotransmission associated with agitation in AD pathology^3,7.

The API have been shown to regulate cannabinoid CB1r imbalances in brain networks associated with aggressive behaviors in animal models^4,6 and agitation in Alzheimer’s².

IGC-AD1's Two APIs -
Multiple Modes of Action

Pre-clinical

Preclinical studies have allowed us to identify the potential of IGC-AD1 to be an AD-modifying drug. The combination of the active ingredients at low, non-toxic concentrations was shown to reduce Aβ aggregation in N2aAβPPswe cells, maintain APP levels, and enhance mitochondrial function in a dose-dependent manner⁵.

Phase I Clinical Trial

Study Design:
The study involved participants with mild to moderate Alzheimer’s disease to evaluate the safety and tolerability of IGC-AD1.

Results: IGC-AD1 was found to be safe and tolerable at three different dosage levels.

– Improvements were observed in Neuropsychiatric Symptoms (NPS) and Caregiver Distress.

Phase II Clinical Trial
brings hope

As millions of Alzheimer’s patients present agitation, our ongoing Phase 2 trial brings hope for a treatment.

Clinical trial includes up to 20 sites in the U.S. and Canada with a target of 146 participants.

As an oral liquid solution, IGC-AD1 could be an effective, simpler treatment option for patients

The API combination in the oral formulation is patent-protected

IGC-AD1 incorporates low concentration of a plant-derived API

Phase 1 clinical trials demonstrated that IGC-AD1 is safe and well tolerated at different dosages

REFERENCES

Yasuno F, Kimura Y, Ogata A, Ikenuma Abe J, Minami H, Nihashi T, Yokoi K, Hattori S, Shimoda N, Watanabe A, Kasuga K, Ikeuchi T, Takeda A, Sakurai T, Ito K, Kato T. Involvement of inflammation in the medial temporal region in the development of agitation in Alzheimer’s disease: an in vivo positron emission tomography study. Psychogeriatrics. 2023 Jan;23(1):126-135. doi: 10.1111/psyg.12915. Epub 2022 Nov 20. PMID: 36403981; PMCID: PMC10100091.
Outen JD, Burhanullah MH, Vandrey R, Amjad H, Harper DG, Patrick RE, May RL, Agronin ME, Forester BP, Rosenberg PB. Cannabinoids for Agitation in Alzheimer’s Disease. Am J Geriatr Psychiatry. 2021 Dec;29(12):1253-1263. doi: 10.1016/j.jagp.2021.01.015. Epub 2021 Jan 27. PMID: 33573996; PMCID: PMC8313629.
Lindenmayer JP. The pathophysiology of agitation. J Clin Psychiatry. 2000;61 Suppl 14:5-10. PMID: 11154018.
Rosenberg PB, Nowrangi MA, Lyketsos CG. Neuropsychiatric symptoms in Alzheimer’s disease: What might be associated brain circuits? Mol Aspects Med. 2015 Jun-Oct;43-44:25-37. doi: 10.1016/j.mam.2015.05.005. Epub 2015 Jun 3. PMID: 26049034; PMCID: PMC4600424.
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Rodriguez-Arias M, Navarrete F, Daza-Losada M, Navarro D, Aguilar MA, Berbel P, Miñarro J, Manzanares J. CB1 cannabinoid receptor-mediated aggressive behavior. Neuropharmacology. 2013 Dec;75:172-80. doi: 10.1016/j.neuropharm.2013.07.013. Epub 2013 Aug 2. PMID: 23916480.
Roy J, Tsui KC, Ng J, Fung ML, Lim LW. Regulation of Melatonin and Neurotransmission in Alzheimer’s Disease. Int J Mol Sci. 2021 Jun 25;22(13):6841. doi: 10.3390/ijms22136841. PMID: 34202125; PMCID: PMC8268832