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NCT05557409CompletedPhase 3

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

ADVANCE-2: Addressing Dementia Via Agitation-Centered Evaluation 2: A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Alzheimer's Disease Agitation

Source: ClinicalTrials.gov · Last updated 13 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
408 (actual)
First submitted
23 Sept 2022
Start date
6 Sept 2022
Primary completion date
21 Nov 2024
Lead sponsor
Axsome Therapeutics, Inc.
NCT number
NCT05557409

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 408
  • From 6 Sept 2022 to the primary completion date, 21 Nov 2024
  • 48 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patient has dementia predominantly of non-Alzheimer's type.

Other

  • Unable to comply with study procedures.
  • Medically inappropriate for study participation in the opinion of the investigator.

Who the study is looking for

  • Diagnosis of probable Alzheimer's disease (AD) based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria.
  • Diagnosis of clinically significant agitation resulting from probable AD according to the International Psychogeriatric Association (IPA) provisional definition of agitation.

Age in the registry: 65 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (48)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BayamónPuerto RicoUnknown status
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San JuanPuerto RicoUnknown status
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ArlingtonUnited StatesUnknown status
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AugustaUnited StatesUnknown status
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AustinUnited StatesUnknown status
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BerlinUnited StatesUnknown status
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Bonita SpringsUnited StatesUnknown status
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BraintreeUnited StatesUnknown status
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BrandonUnited StatesUnknown status
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BrooklynUnited StatesUnknown status
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Canoga ParkUnited StatesUnknown status
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CharlotteUnited StatesUnknown status
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ChesterfieldUnited StatesUnknown status
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College ParkUnited StatesUnknown status
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ColumbusUnited StatesUnknown status
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CypressUnited StatesUnknown status
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FlintUnited StatesUnknown status
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Green AcresUnited StatesUnknown status
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HialeahUnited StatesUnknown status
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HickoryUnited StatesUnknown status
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HollywoodUnited StatesUnknown status
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KissimmeeUnited StatesUnknown status
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Long BeachUnited StatesUnknown status
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Los AlamitosUnited StatesUnknown status
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MarreroUnited StatesUnknown status
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MesquiteUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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Miami GardensUnited StatesUnknown status
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Miami LakesUnited StatesUnknown status
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Middleburg HeightsUnited StatesUnknown status
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New WindsorUnited StatesUnknown status
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OrlandoUnited StatesUnknown status
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Pembroke PinesUnited StatesUnknown status
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PeoriaUnited StatesUnknown status
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Rochester HillsUnited StatesUnknown status
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RutlandUnited StatesUnknown status
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San AntonioUnited StatesUnknown status
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Staten IslandUnited StatesUnknown status
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SugarlandUnited StatesUnknown status
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TampaUnited StatesUnknown status
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TempeUnited StatesUnknown status
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Toms RiverUnited StatesUnknown status
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TroyUnited StatesUnknown status
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TucsonUnited StatesUnknown status
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Walnut CreekUnited StatesUnknown status
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West CovinaUnited StatesUnknown status
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WichitaUnited StatesUnknown status
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WoodmereUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.