Trial ID: NCT06808984
Sponsor: Celgene (Bristol Myers Squibb)
Status: Recruiting
Phase: Phase 2
Participants: 120
BMS-986368 is a Phase 2 clinical trial conducted by Celgene (Bristol Myers Squibb) investigating a novel therapeutic approach for agitation in Alzheimer's disease. The trial is currently recruiting participants, representing Celgene/BMS's continued investment in neuropsychiatric symptoms of dementia.
Agitation is one of the most common and challenging behavioral and psychological symptoms of dementia (BPSD), affecting up to 70% of patients during the disease course[1]. It encompasses a spectrum of behaviors including restlessness, aggression, disinhibition, and pacing that significantly impact quality of life for both patients and caregivers.
| Parameter | Value |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting |
| Enrollment | 120 participants |
| Sponsor | Celgene (Bristol Myers Squibb) |
| Condition | Agitation in Alzheimer's Disease |
| Study Type | Interventional |
| Allocation | Randomized |
While the specific molecular mechanism of BMS-986368 has not been publicly disclosed, the therapeutic approach likely targets one or more of the key pathways implicated in Alzheimer's-related agitation:
Neuroinflammation is increasingly recognized as a central contributor to behavioral symptoms in Alzheimer's disease. Key mechanisms include:
Agitation in AD involves dysregulation of multiple neurotransmitter systems:
Celgene/BMS has historically focused on innovative approaches to CNS disorders:
Agitation represents one of the most significant unmet needs in Alzheimer's disease management[2]:
| Treatment | Limitations |
|---|---|
| Atypical antipsychotics | Increased mortality, stroke, cognitive decline |
| Typical antipsychotics | Extrapyramidal symptoms, TD risk |
| Benzodiazepines | Falls, cognitive worsening, dependence |
| Mood stabilizers | Variable efficacy, toxicity concerns |
| Non-pharmacological | Limited efficacy in moderate-severe agitation |
This therapeutic gap underscores the need for novel agents like BMS-986368 that target underlying disease mechanisms rather than simply suppressing symptoms[3].
Celgene (acquired by Bristol Myers Squibb in 2019) has a robust neuroscience research program focusing on:
Key areas of investigation include:
BMS-986368 represents one of several CNS candidates in the Celgene/BMS pipeline:
| Compound | Target | Indication | Stage |
|---|---|---|---|
| BMS-986368 | undisclosed | AD Agitation | Phase 2 |
| Various | HDAC | Neurodegeneration | Preclinical |
| Multiple | Immune modulators | MS, ALS | Various |
While specific endpoints are detailed on ClinicalTrials.gov, Phase 2 trials typically evaluate:
Commonly used measures for agitation trials include:
Given the patient population, special safety considerations include:
The development of BMS-986368 is significant for several reasons:
Cerejeira J, Lagarto L, Mukaetova-Ladinska EB. Behavioral and psychological symptoms of dementia. Frontiers in Neurology. 2012. ↩︎
Lyketsos CG, Carrillo MC, Ryan JM, et al. Neuropsychiatric symptoms in Alzheimer's disease. Alzheimer's & Dementia. 2011. ↩︎
Geda YE, Schneider LS, Gitlin LN, et al. Neuropsychiatric symptoms in Alzheimer's disease. Molecular Psychiatry. 2013. ↩︎