# An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study

> **NCT06736509** · PHASE3 · TERMINATED · sponsor: **Axsome Therapeutics, Inc.** · enrollment: 139 (actual)

## Conditions studied

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

## Interventions

- **DRUG:** AXS-05 (dextromethorphan-bupropion)

## Key facts

- **NCT ID:** NCT06736509
- **Lead sponsor:** Axsome Therapeutics, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2024-11-21
- **Primary completion:** 2025-02-17
- **Final completion:** 2025-04-25
- **Target enrollment:** 139 (ACTUAL)
- **Why stopped:** Study AXS-05-AD-305 was terminated due to completion of overall program objectives.
- **Last updated:** 2026-02-19


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06736509

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06736509, "An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study". Retrieved via AI Analytics 2026-07-17 from https://api.ai-analytics.org/clinical/NCT06736509. Licensed CC0.

---

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