The promise of
Pre-clinical and Phase 1 studies indicate that IGC-AD1 could safely reduce the debilitating symptoms that impact millions of Alzheimer’s patients.
Low doses of THC, a natural component of cannabis, can provide medical benefits.
The Phase 1 and Phase 2 trials are registered on clinicaltrials.gov
IGC Pharma begins development of the IGC-AD1 oral formulation
IGC-AD1 is approved by the FDA as an investigational new drug
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.
Phase 2 clinical trial to evaluate the efficacy of IGC-AD1 begins
Additional patent awarded protecting IGC-AD1 formulation
Our 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 10 sites in the U.S. and Canada with a target of 146 participants.
Why IGC-AD1 & Alzheimer’s?
IGC-AD1 contains two Active Pharmaceutical Ingredients (APIs),
one of them is THC.
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 contains two active pharmaceutical ingredients including low doses of THC
THC is a natural component of cannabis
Learn more about THC and Cannabis
- THC (∆9-tetrahydrocannabinol) is a psychoactive compound in the cannabis plant that is commonly associated with a euphoric high at high doses
- A low dose of THC is an active pharmaceutical ingredient in IGC-AD1
- The FDA has approved synthetic THC-based formulations for treating nausea and vomiting caused by chemotherapy
How is THC
IGC Pharma has production capabilities to safely and legally procure THC from cannabis at scale.
The pre-clinical studies tested the API in IGC-AD1 on Alzheimer’s cell lines and Alzheimer’s mouse models and found that it had the potential to be a disease modifying drug that could:
Detailed scientific results
IGC-AD1 reduces Aβ40 peptide production and Aβ42 aggregation in Alzheimer’s cell lines.
Representation of Cao et al., 2014
In Alzheimer’s cell line tests, IGC-AD1 increased Aβ monomers and decreased Aβ aggregation in a dose–dependent manner and decreased Aβ aggregation.
Representation of Cao et al., 2014
IGC-AD1 did not reduce Amyloid Precursor Protein (APP) levels in Alzheimer’s cell lines.
APP modulates cell growth, motility, and survival; it is cut to create small fragments such as the Aβ peptide. Representation of Cao et al., 2014
Memory Improved in Alzheimer’s Mice Model
In a Morris Water Maze test, mice dosed with the active agent in IGC-AD1 had significantly improved times and less errors than those in the control group demonstrating that memory improved in transgenic (APP/PS1) mice with IGC-AD1. group.
Nature Protocols. 2006; 1: 848-858; Int. J. Mol. Sci. 2022, 23, 2757
Over 48 hours, repeated low-dose exposure to IGC-AD1 was not toxic to Alzheimer’s cells.
Overall Study Design:
Participants with mild to severe Alzheimer’s disease
Participants were sequentially administered three doses over 14 days: once a day (QD), twice a day (BID), and three times a day (TID)
Evaluate safety and tolerability of IGC-AD1 measured by patient-reported and observed Adverse Events.
Measure any changes to neuropsychiatric symptoms (NPS) as measured by the neuropsychiatric inventory (NPI-12).
80.46 ± 5.71 y.o.
147.66 ± 31.62 lb.
5.28 ± 0.46 ft.
41.77 ± 8.86
Phase 1 clinical trial
The Phase 1 Clinical trial included patients with mild to severe Alzheimer’s. The trial showed that:
- IGC-AD1 is safe and tolerable at three different dosage levels.
- Caregiver distress, and Neuropsychiatric Symptoms (NPS), including agitation, anxiety, and depression improved.
- The impact of IGC-AD1 on the Neuropsychiatric Inventory (NPI) score for agitation was improved at all three dosage levels.
- IGC-AD1 also decreased the NPI score for both anxiety and depression.
Phase 1 Clinical Study Results
Results on NPS:
Patients taking IGC-AD1 intervention showed an overall improvement in NPS, including
agitation, anxiety, depression, and caregiver distress.
At all three dosages, agitation improved both clinically and statistically (p <05).
IGC-AD1 decreased the NPI score for both the anxiety and depression.
IGC-AD1 decreased the NPI score in both the Anxiety and Depression domains.