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
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.
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:
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.
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
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
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.
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 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.