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IGC-AD1-Active

Phase 2

Alzheimer Disease | Small molecule | Neurology |IGC Pharma, Inc.|Last Updated: May 20, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment164
FDA Designations
No designations recorded
Clinical trial landscape

IGC-AD1-Active · 1 trial · 5 indications

Phase 2 1
NCT05543681Clinical Trial on Agitation in Alzheimer's DementiaAlzheimer Disease
RECRUITING164 Analytics
PHASE2RECRUITING
Clinical Trial on Agitation in Alzheimer's Dementia
Alzheimer DiseaseUnlock trial analytics
Study Endpoints
Primary Endpoints
Agitation
Baseline to week six

Change in mean Cohen Mansfield Agitation Inventory (CMAI) score

Secondary Endpoints
Acute Agitation
Baseline to week two
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Active Comparator: IGC-AD1ActiveACTIVE_COMPARATORIGC-AD1-Active, oral solution with two APIs (THC and melatonin).
Placebo Comparator: IGC-AD1 PlaceboPLACEBO_COMPARATORIGC-AD1-Placebo, oral solution similar to Active in color, taste, and texture, with excipients but without APIs.
Interventions
NameTypeDescription
IGC-AD1-ActiveDRUGA non-sterile solution for oral administration.
IGC-AD1-PlaceboDRUGA non-sterile solution for oral administration similar in color and texture to the Active.
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Eligibility Criteria
Age Range60 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites31

To be eligible to participate in this study, the participant must meet all the following criteria: Inclusion Criteria 1. Participant and/or Caregiver must provide a signed and dated ICF prior to any study procedures. 2. Must have a Caregiver who is able and willing to comply with all required stud...

Countries:United StatesCanadaColombiaPuerto Rico
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT05543681primaryCompletionDate: changed
LOWMay 24, 2026NCT05543681studyFirstPostDate: changed