Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05543681 | Clinical Trial on Agitation in Alzheimer's Dementia | PHASE2 | RECRUITING | 164 | — | — | Oct 11, 2022 | Aug 1, 2026 | May 20, 2026 | 31 | United States, Canada +2 |
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...