Alzheimer Disease / Agitation / BMS-986368 · Phase 2 Trial

Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease

ClinicalTrials.gov · August 13, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 trial registration for BMS-986368, a FAAH/MAGL inhibitor, in agitation associated with Alzheimer's disease. No results are reported in this registry record; the trial is currently recruiting. Efficacy and safety data are not yet available for clinical assessment.

What was studied

Phase 2, Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Agitation, Alzheimer Disease; age from 55 Years; to 90 Years. Intervention: BMS-986368 Dose 1; BMS-986368 Dose 2. Compared with: Placebo — Placebo Comparator. n = 120. 75 sites across 4 countries.

Key findings

Safety

This is a registry record only; no efficacy, safety, or tolerability results are reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 2 trial registration with no reported results; enrollment is ongoing and efficacy data are not yet available.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline (assessed at Up to Week 8)

DesignPhase 2, Interventional, Randomized, Parallel, Triple masking, Treatment purpose

PopulationAgitation, Alzheimer Disease; age from 55 Years; to 90 Years

Sample size120

InterventionBMS-986368 Dose 1; BMS-986368 Dose 2

ComparatorPlacebo — Placebo Comparator

Setting75 sites across 4 countries

Reported figures

Quoted from the source exactly as published.

Planned sample size120

PhasePHASE 2

Primary outcome measureChange in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline, Up to Week 8

Study statusRECRUITING

Caveats

This is a registry record only; no efficacy, safety, or tolerability results are reported.
Enrollment is ongoing (RECRUITING status); final sample size and follow-up data are not yet available.
Study design details such as blinding method, randomization procedure, and dose of BMS-986368 are not provided in the registry record.
No comparisons to published data on other agitation treatments are provided.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 interventional trial with placebo comparator; design supports proof-of-concept but not definitive efficacy.

Directness

strong

Primary endpoint directly measures agitation in Alzheimer's disease patients using validated CMAI scale.

Consistency

insufficient

Registry record only; no results reported; consistency cannot be assessed.

Risk of bias

insufficient

Placebo-controlled design reduces bias, but blinding and allocation concealment not detailed in registry.

Sample adequacy

limited

Planned enrollment 120 participants; modest for Phase 2, typical of early efficacy studies.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06808984). This is a study registration, not published results. Lead sponsor: Celgene. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 120 participants (ESTIMATED). Conditions: Agitation, Alzheimer Disease. Interventions: DRUG: BMS-986368; DRUG: Placebo. Primary outcome measures: Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline , Up to Week 8. Brief summary: This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH/MAGL inhibitor, for the treatment of agitation in participants with Alzheimer's Disease.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

CelgeneNCT06808984Alzheimer DiseaseAgitationBMS-986368