# A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation

> **NCT05557409** · PHASE3 · COMPLETED · sponsor: **Axsome Therapeutics, Inc.** · enrollment: 408 (actual)

## Conditions studied

- Agitation in Patients With Dementia of the Alzheimer's Type
- Alzheimer Disease
- Agitation

## Interventions

- **DRUG:** AXS-05
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT05557409
- **Lead sponsor:** Axsome Therapeutics, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2022-09-06
- **Primary completion:** 2024-11-21
- **Final completion:** 2024-12-21
- **Target enrollment:** 408 (ACTUAL)
- **Last updated:** 2025-11-26


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05557409

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05557409, "A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT05557409. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*