Approval Probability
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Also known as IGC-AD1-Active
IGC-AD1 · 2 trials · 6 indications
Change in mean Cohen Mansfield Agitation Inventory (CMAI) score
Evaluate safety and tolerability of IGC AD1 10 participants will be administered the investigational drug and two will be administered placebo. Incidence of treatment emergent adverse events will be assessed to determine safety and tolerability of IGC-AD1.
| 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. |
| Active | ACTIVE_COMPARATOR | IGC AD1 |
| Placebo | PLACEBO_COMPARATOR | IGC AD1 Placebo |
| 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. |
| IGC AD1 | DRUG | IGC AD1 oral Solution |
| Placebo | DRUG | Placebo of IGC AD1 oral Solution |
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 is an investigational small molecule being developed by IGC Pharma, Inc. for Alzheimer disease and dementia of the Alzheimer type. It is in Phase 2 clinical development and is being studied primarily for agitation in Alzheimer's dementia. It has not been approved by the FDA.
IGC-AD1 is being studied for agitation in Alzheimer's dementia, including psychomotor agitation, aggression, and caregiver burden, as well as for dementia due to Alzheimer's disease. It is investigational and has not been approved for any indication.
IGC-AD1 is developed by IGC Pharma, Inc., which trades under the ticker IGC. The company is the sponsor of the clinical program evaluating the drug in Alzheimer disease and related dementia.
IGC-AD1 is in Phase 2 clinical development. A Phase 2 trial in agitation in Alzheimer's dementia is active but not recruiting, and a Phase 1 study in dementia due to Alzheimer's disease has been completed. The drug remains investigational.
IGC-AD1 has been evaluated in two registered trials. NCT05543681 is a Phase 2 trial in agitation in Alzheimer's dementia with 164 participants across the United States, Canada, and Puerto Rico. NCT04749563 was a completed Phase 1 study in dementia due to Alzheimer's disease with 12 participants in Puerto Rico.
Yes. IGC-AD1 is also referred to as IGC-AD1-Active and IGC AD1. These names refer to the same investigational small molecule developed by IGC Pharma, Inc. for Alzheimer disease and dementia of the Alzheimer type.