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Also known as [14C]-BMS-986368, BMS-986368, Irafamdastat
CC-97489 · 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...
CC-97489 is an investigational small molecule being developed by Bristol-Myers Squibb Company. It has been studied in a Phase 1 positron emission tomography imaging trial in healthy volunteers to evaluate enzyme availability in the central nervous system. Its therapeutic indication has not been disclosed.
CC-97489 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the Phase 1 PET imaging study of the compound conducted in Belgium.
CC-97489 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound is investigational and has not been approved for any indication.
CC-97489 was evaluated in NCT05065541, a Phase 1 positron emission tomography imaging study titled Positron Emission Tomography (PET) Imaging Study to Evaluate Enzyme Availability in the Central Nervous System Before and After CC-97489 Administration in Healthy Participants. The trial enrolled 32 healthy volunteers in Belgium and has been completed.
The completed Phase 1 trial of CC-97489, NCT05065541, was not randomized and was not double blinded. It used a controlled design and enrolled 32 healthy volunteers aged 18 years and older in Belgium. The study assessed enzyme availability in the central nervous system using PET imaging.