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IGC-AD1-Active · 1 trial · 5 indications
Change in mean Cohen Mansfield Agitation Inventory (CMAI) score
| Arm | Type | Description |
|---|---|---|
| Active Comparator: IGC-AD1Active | ACTIVE_COMPARATOR | IGC-AD1-Active, oral solution with two APIs (THC and melatonin). |
| Placebo Comparator: IGC-AD1 Placebo | PLACEBO_COMPARATOR | IGC-AD1-Placebo, oral solution similar to Active in color, taste, and texture, with excipients but without APIs. |
| Name | Type | Description |
|---|---|---|
| IGC-AD1-Active | DRUG | A non-sterile solution for oral administration. |
| IGC-AD1-Placebo | DRUG | A non-sterile solution for oral administration similar in color and texture to the Active. |
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...
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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.
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.
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.
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.
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.
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.