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
← catalyst calendarSponsored by Axsome Therapeutics, Inc. (industry) · AXSM — their whole pipeline →.
Phase
Phase 3
Status
Terminated
Study type
Interventional
Design
Na · None · Treatment
Enrollment
139actual
Sites
22
Countries
Puerto Rico, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Study AXS-05-AD-305 was terminated due to completion of overall program objectives.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-11-21 | actual | When the study began enrolling |
| Primary completion | 2025-02-17 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-04-25 | actual | The whole study's end, after follow-up |
| First posted | 2024-12-16 | actual | When this record first appeared on the registry |
| Results posted | 2026-06-25 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-06-25 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type
- Alzheimer Disease
- Agitation, Psychomotor
Intervention
- Drug: AXS-05 (dextromethorphan-bupropion)
Primary outcome
what the primary-completion date above is the date OFLong-Term Safety
measured Up to 25 weeks
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2024-10-18 · 399 KB · Prot_SAP_000.pdf
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