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.

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 I Clinical Trial Results

  • IGC-AD1 is safe and tolerable at three different dosage levels.
  • Caregiver distress, and Neuropsychiatric Symptoms (NPS), including agitation, anxiety, and depression improved.

Phase I 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. 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 NPS: Neuropsychiatric Symptoms Measured by NPI Scores

Patients taking IGC-AD1 intervention showed an overall improvement in NPS. Caregiver distress improved as well. 

Results on Agitation

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