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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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Frequently asked questions about IGC-AD1-Active

What is IGC-AD1-Active used for?

IGC-AD1-Active is an investigational small molecule being developed for the treatment of agitation in Alzheimer's disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being studied in patients with Alzheimer's disease who experience symptoms such as psychomotor agitation, aggression, and related neuropsychiatric symptoms.

How does IGC-AD1-Active work?

The specific molecular target and mechanism of action for IGC-AD1-Active have not been disclosed. The drug is being investigated for its potential to reduce agitation and aggression in patients with Alzheimer's disease, but the precise biological pathway through which it exerts its effects is not publicly available.

Who is developing IGC-AD1-Active?

IGC-AD1-Active is being developed by IGC Pharma, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol IGC. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug for Alzheimer's disease-related agitation.

What phase is IGC-AD1-Active in?

IGC-AD1-Active is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not received FDA approval and is still undergoing clinical trials to assess its safety and effectiveness. The ongoing Phase 2 trial is recruiting participants to evaluate the drug's impact on agitation in Alzheimer's disease.

What clinical trials is IGC-AD1-Active in?

IGC-AD1-Active is being evaluated in a Phase 2 clinical trial registered as NCT05543681. This randomized, double-blind, placebo-controlled study is recruiting 164 participants aged 60 years and older with Alzheimer's disease and agitation. The trial is being conducted at sites in the United States, Canada, Colombia, and Puerto Rico.

Is IGC-AD1-Active the same as other Alzheimer's drugs?

IGC-AD1-Active is a distinct investigational drug candidate developed by IGC Pharma. It is not known to be the same as any other marketed or investigational Alzheimer's disease treatment. Its unique formulation and development history differentiate it from other drugs in this therapeutic area.