Phase I Clinical Trial
Overall Study Design:
- Participants with mild to moderate 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 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
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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).
