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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 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 awarded patent protection in México 

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 20 sites in the U.S. and Canada with a target of 146 participants.

Why IGC-AD1 & Alzheimer’s?

IGC-AD1 includes two Active Pharmaceutical Ingredients (APIs) 

The APIs in IGC-AD1 have been shown to reduce the plaque build-up associated with Alzheimer’s in cell lines.

The API have been shown to promote mitochondrial functioning in pre-clinical studies

The API have been shown to restore spatial memory in a mouse model of Alzheimer’s.

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

IGC-AD1

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 obtained from cannabis? IGC Pharma has production capabilities to safely
and legally procure THC from cannabis at scale

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How is THC
obtained
from cannabis?

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IGC Pharma has production capabilities to safely and legally procure THC from cannabis at scale.

Pre-clinical study results

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: 

  • Inhibit the formation of neurofibrillary tangles
  • Inhibit the formation of plaques.
  • Enhance mitochondrial functioning.
  • Improve spatial memory.

Pre-clinical studies:
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 dosedependent 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. 

  • Aβ Production
    & Aggregation
  •  The API in IGC-AD1 reduces Aβ40 peptide production and Aβ42 aggregation in Alzheimer’s cell lines.  

     

    Representation of Cao et al., 2014

  • Aβ Monomers
  • In Alzheimer’s cell lines, IGC-AD1 increased Aβ monomers and decreased Aβ aggregation in a dosedependent manner.


    Representation of Cao et al., 2014

  • APP Levels
  • The APIs in 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 that eventually deposit as plaque. 

    Representation of Cao et al., 2014

  • Spatial Memory
  • Memory Improved
    in Alzheimer’s Mice Model

    In a Morris Water Maze test, mice dosed with the API 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.

    Nature Protocols. 2006; 1: 848-858; Int. J. Mol. Sci. 2022, 23, 2757
  • Neurotoxicity
  • Over 48 hours, repeated low-dose exposure to the API in IGC-AD1 was not toxic to Alzheimer’s cells (N2a/AßPPsWe cells). 

    Representation of Cao et al., 2014

 The API in IGC-AD1 reduces Aβ40 peptide production and Aβ42 aggregation in Alzheimer’s cell lines.  

 

Representation of Cao et al., 2014

In Alzheimer’s cell lines, IGC-AD1 increased Aβ monomers and decreased Aβ aggregation in a dosedependent manner.


Representation of Cao et al., 2014

The APIs in 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 that eventually deposit as plaque. 

Representation of Cao et al., 2014

Memory Improved
in Alzheimer’s Mice Model

In a Morris Water Maze test, mice dosed with the API 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.

Nature Protocols. 2006; 1: 848-858; Int. J. Mol. Sci. 2022, 23, 2757

Over 48 hours, repeated low-dose exposure to the API in IGC-AD1 was not toxic to Alzheimer’s cells (N2a/AßPPsWe cells). 

Representation of Cao et al., 2014

Phase1
Clinical Trial

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)

  • Double-blind

Objectives

Primary

Evaluate safety and tolerability of IGC-AD1 measured by patient-reported and observed Adverse Events. 

Secondary

Measure any changes to Neuropsychiatric Symptoms (NPS) as measured by the Neuropsychiatric Inventory (NPI-12

Demographics

Female
69.2%

Male
30.8%

Age
80.46 ± 5.71 y.o.

Weight
147.66 ± 31.62 lb.

Height
5.28 ± 0.46 ft.

BMI
21.58 ± 1.02 

Phase 1 clinical trial
results

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.

Phase 1 Clinical Study Results

  • Results on NPS
  • Results on NPS: Neuropsychiatric Symptoms Measured by NPI Scores

    Patients taking IGC-AD1 intervention showed an overall improvement in NPS, and specifically in  agitation, anxiety, and depression domains. Caregiver distress improved as well. 

  • Results on Agitation
  • Results on Agitation

    At all three dosages, agitation improved both clinically and statistically (p <0.05).

     

  • Results on Anxiety and Depression
  • IGC-AD1 decreased the NPI scores for the anxiety and depression domains. 

Results on NPS: Neuropsychiatric Symptoms Measured by NPI Scores

Patients taking IGC-AD1 intervention showed an overall improvement in NPS, and specifically in  agitation, anxiety, and depression domains. Caregiver distress improved as well. 

Results on Agitation

At all three dosages, agitation improved both clinically and statistically (p <0.05).

 

IGC-AD1 decreased the NPI scores for the anxiety and depression domains. 

Results on NPS:

Patients taking IGC-AD1 intervention showed an overall improvement in NPS, including  

agitation, anxiety, depression, and caregiver distress. 

 

 

Agitation Results

At all three dosages, agitation improved both clinically and statistically (p <0.05).

 


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.