Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-986368 · 6 trials · 5 indications
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 | - |
| Administration of BMS-986368 Dose A | EXPERIMENTAL | - |
| Administration of BMS-986368 Dose B | EXPERIMENTAL | - |
| Administration of BMS-986368 Dose C | EXPERIMENTAL | - |
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Cohort 1A | EXPERIMENTAL | - |
| Cohort 1B | EXPERIMENTAL | - |
| Cohort 1C | EXPERIMENTAL | - |
| Cohort 2A | EXPERIMENTAL | - |
| Cohort 2B | EXPERIMENTAL | - |
| Cohort 2C | EXPERIMENTAL | - |
| Cohort 2D | EXPERIMENTAL | - |
| Cohort 3A | EXPERIMENTAL | - |
| Cohort 3B | EXPERIMENTAL | - |
| Part 1: BMS-986368 - Fasted | EXPERIMENTAL | - |
| Part 1: Itraconazole - Fasted | EXPERIMENTAL | - |
| Part 1: BMS-986368 with Itraconazole - Fasted | EXPERIMENTAL | - |
| Part 2: BMS-986368 - Fasted | EXPERIMENTAL | - |
| Part 2: BMS-986368 - Fed | EXPERIMENTAL | - |
| Part 2: Famotidine, followed by BMS-986368 - Fasted | EXPERIMENTAL | - |
| [14C]-BMS-986368 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BMS-986368 | DRUG | Specified dose on specified days |
| Placebo | DRUG | Specified dose on specified days |
| BMS-986368-matching Placebo | OTHER | Specified dose of specified days |
| Itraconazole | DRUG | Specified dose on specified days |
| Famotidine | DRUG | Specified dose on specified days |
| [14C]-BMS-986368 | 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...
BMS-986368 is an investigational small molecule being studied for neurological conditions. It is in Phase 2 clinical trials for multiple sclerosis spasticity and for agitation in Alzheimer's disease. It has also been studied in healthy volunteers to evaluate its absorption, metabolism, and excretion.
BMS-986368 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials for this investigational drug in neurology indications.
BMS-986368 is in Phase 2 clinical development. It is being studied in Phase 2 trials for multiple sclerosis spasticity and for agitation in Alzheimer's disease. It is not approved by regulatory authorities and remains an investigational drug.
BMS-986368 is being studied in several trials. NCT06782490 is a Phase 2 trial for multiple sclerosis spasticity with 200 participants. NCT06808984 is a Phase 2 trial for agitation in Alzheimer's disease with 120 participants. NCT07700329 is a Phase 1 trial in healthy Chinese participants.
Yes, BMS-986368 has been studied in healthy volunteers. NCT06227975 was a completed Phase 1 study in healthy male participants in the United States. NCT07700329 is a Phase 1 study planned in healthy Chinese participants to evaluate blood levels, safety, and tolerability.
The molecular target of BMS-986368 has not been disclosed in the available clinical trial information. The drug is being investigated for its effects on multiple sclerosis spasticity and agitation in Alzheimer's disease, but its specific mechanism of action is not stated.