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Agitation in Patients With Dementia of the Alzheimer's Type / Alzheimer Disease / Agitation · Phase 3 Trial
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed Phase 3 randomized controlled trial comparing AXS-05 to placebo for agitation in Alzheimer's disease, with 408 enrolled participants and CMAI as the primary outcome assessed over 5 weeks. No efficacy or safety results are posted in this registry record; the trial design is rigorous but the evidence cannot be evaluated until outcomes are reported.
Phase 3, Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation; age from 65 Years; to 90 Years. Intervention: AXS-05. Compared with: Placebo — Placebo Comparator. n = 408. 55 sites: United States, Puerto Rico.
This is a completed Phase 3 randomized controlled trial comparing AXS-05 to placebo for agitation in Alzheimer's disease, with 408 enrolled participants and CMAI as the primary outcome assessed over 5 weeks. No efficacy or safety results are posted in this registry record; the trial design is rigorous but the evidence cannot be evaluated until outcomes are reported.
This is a registry record only; no efficacy or safety results are reported.
The source did not state who this applies to in practice.
Phase 3 RCT with completed enrollment and defined primary endpoint, but no results posted in this registry record; the design is sound but outcomes remain unreported.
As stated by the source record.
Quoted from the source exactly as published.
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.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05557409). This is a study registration, not published results. Lead sponsor: Axsome Therapeutics, Inc.. Recruitment status: COMPLETED. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 408 participants (ACTUAL). Conditions: Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation. Interventions: DRUG: AXS-05; DRUG: Placebo. Primary outcome measures: Cohen-Mansfield Agitation Inventory (CMAI) , Up to 5 weeks. Brief summary: This trial was a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of agitation associated with Alzheimer's disease.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.