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Also known as [14C]-BMS-986368, CC-97489, Irafamdastat
BMS-986368 · 4 trials · 4 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 | - |
| Treatment A | EXPERIMENTAL | - |
| Treatment B | EXPERIMENTAL | - |
| Treatment C | EXPERIMENTAL | - |
| Treatment D | EXPERIMENTAL | - |
| Treatment E | EXPERIMENTAL | - |
| Part 1 | EXPERIMENTAL | - |
| Part 2 | EXPERIMENTAL | - |
| Part 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BMS-986368 | DRUG | Specified dose on specified days |
| Placebo | DRUG | Specified dose on specified days |
| Irafamdastat | DRUG | Specified dose on specified days. |
| CC-97489 | DRUG | Specified dose on specified days |
| [18F]T-401 | DRUG | Specified dose on specified days |
| [11C]MK-3168 | 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 developed by Bristol-Myers Squibb for neurological conditions. It is in Phase 2 clinical development for agitation in Alzheimer's disease and for multiple sclerosis spasticity. It is not approved for any indication and remains under clinical study.
BMS-986368 is being studied for two neurological indications: agitation in people with Alzheimer's disease and spasticity in people with multiple sclerosis. Both uses are investigational and are being evaluated in Phase 2 clinical trials. The drug has no approved uses.
Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY, is the developer of BMS-986368. The company is running the Phase 2 clinical program evaluating the small molecule in agitation associated with Alzheimer's disease and in multiple sclerosis spasticity.
BMS-986368 is in Phase 2 clinical development. Two Phase 2 trials are currently recruiting, one in agitation in Alzheimer's disease and one in multiple sclerosis spasticity. The drug is investigational and has not been approved by the FDA for any indication.
BMS-986368 is being evaluated in two recruiting Phase 2 trials. NCT06808984 studies its efficacy, safety, and tolerability in agitation in participants with Alzheimer's disease across the United States, Argentina, Australia, and China. NCT06782490 studies it in multiple sclerosis spasticity across the United States, Australia, Canada, Czechia, Germany, Poland, and Puerto Rico.
Yes, [14C]-BMS-986368 is an alternative name for BMS-986368. The carbon-14 label refers to a radiolabeled form used in research, while BMS-986368 is the compound itself. Both names refer to the same Bristol-Myers Squibb small molecule in Phase 2 development for neurological indications.