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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06808984 | Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease | PHASE2 | RECRUITING | 120 | — | — | Jun 9, 2025 | Jan 7, 2028 | Jun 2, 2026 | 53 | United States |
The CMAI is a scale administered by qualified rater based on caregiver's input on 29 items that assess the frequency of manifestations of agitated behaviors in older adults. Each item is rated on a 7-point scale: 1 = "never", 2 = "less than once a week", 3 = "once or twice a week", 4 = "several times a week", 5 = "once or twice a day", 6 = "several times a day" and 7 = "several times per hour." Ratings pertain to the period of time over the previous 2 weeks preceding administration of the CMAI. CMAI total scores range from 29 to 203.
| Arm | Type | Description |
|---|---|---|
| BMS-986368 Dose 1 | EXPERIMENTAL | - |
| BMS-986368 Dose 2 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BMS-986368 | DRUG | Specified dose on specified days |
| Placebo | DRUG | Specified dose on specified days |
Inclusion Criteria * Participants with a diagnosis of Alzheimer's disease with biomarker confirmation meeting the 2024 Revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup. * The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) defi...