NCT05557409

Brief Summary

This trial is 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2022

Geographic Reach
2 countries

55 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2024

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

2.2 years

First QC Date

September 23, 2022

Last Update Submit

November 20, 2025

Conditions

Agitation in Patients With Dementia of the Alzheimer's TypeAlzheimer DiseaseAgitation

Keywords

AD agitationAXS-05NMDA receptor antagonistdextromethorphanbupropionAxsomeADVANCE-2

Outcome Measures

Primary Outcomes (1)

  • Cohen-Mansfield Agitation Inventory (CMAI)

    Up to 5 weeks

Study Arms (2)

AXS-05

EXPERIMENTAL

Up to 5 weeks

Drug: AXS-05

Placebo

PLACEBO COMPARATOR

Up to 5 weeks

Drug: Placebo

Interventions

AXS-05DRUG

AXS-05 tablets, taken twice daily

AXS-05
PlaceboDRUG

Placebo tablets, taken twice daily

Placebo

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patient has dementia predominantly of non-Alzheimer's type.
  • Unable to comply with study procedures.
  • Medically inappropriate for study participation in the opinion of the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (55)

Clinical Research Site

Peoria, Arizona, 85381, United States

Location

Clinical Research Site

Tempe, Arizona, 85282, United States

Location

Clinical Research Site

Tucson, Arizona, 85710, United States

Location

Clinical Research Site

Canoga Park, California, 91303, United States

Location

Clinical Research Site

Long Beach, California, 90807, United States

Location

Clinical Research Site

Los Alamitos, California, 90720, United States

Location

Clinical Research Site

Walnut Creek, California, 94596, United States

Location

Clinical Research Site

West Covina, California, 91790, United States

Location

Clinical Research Site

Bonita Springs, Florida, 34134, United States

Location

Clinical Research Site

Brandon, Florida, 33511, United States

Location

Clinical Research Site

Greenacres City, Florida, 33467, United States

Location

Clinical Research Site

Hialeah, Florida, 33012, United States

Location

Clinical Research Site

Hollywood, Florida, 33024, United States

Location

Clinical Research Site

Kissimmee, Florida, 34741, United States

Location

Clinical Research Site

Miami, Florida, 33126, United States

Location

Clinical Research Site

Miami, Florida, 33135, United States

Location

Clinical Research Site

Miami, Florida, 33145, United States

Location

Clinical Research Site

Miami, Florida, 33155, United States

Location

Clinical Research Site

Miami, Florida, 33165, United States

Location

Clinical Research Site

Miami, Florida, 33173, United States

Location

Clinical Research Site

Miami, Florida, 33175, United States

Location

Clinical Research Site

Miami Gardens, Florida, 33014, United States

Location

Clinical Research Site

Miami Lakes, Florida, 33014, United States

Location

Clinical Research Site

Orlando, Florida, 32807, United States

Location

Clinical Research Site

Pembroke Pines, Florida, 33025, United States

Location

Clinical Research Site

Tampa, Florida, 33614, United States

Location

Clinical Research Site

Tampa, Florida, 33634, United States

Location

Clinical Research Site

Augusta, Georgia, 30912, United States

Location

Clinical Research Site

College Park, Georgia, 30349, United States

Location

Clinical Research Site

Columbus, Georgia, 31909, United States

Location

Clinical Research Site

Wichita, Kansas, 67214, United States

Location

Clinical Research Site

Marrero, Louisiana, 70072, United States

Location

Clinical Research Site

Braintree, Massachusetts, 02184, United States

Location

Clinical Research Site

Flint, Michigan, 48532, United States

Location

Clinical Research Site

Rochester Hills, Michigan, 48307, United States

Location

Clinical Research Site

Troy, Michigan, 48085, United States

Location

Clinical Research Site

Chesterfield, Missouri, 63005, United States

Location

Clinical Research Site

Berlin, New Jersey, 08009, United States

Location

Clinical Research Site

Toms River, New Jersey, 08755, United States

Location

Clinical Research Site

Brooklyn, New York, 11229, United States

Location

Clinical Research Site

New Windsor, New York, 12553, United States

Location

Clinical Research Site

Staten Island, New York, 10312, United States

Location

Clinical Research Site

Woodmere, New York, 11598, United States

Location

Clinical Research Site

Charlotte, North Carolina, 28211, United States

Location

Clinical Research Site

Hickory, North Carolina, 28601, United States

Location

Clinical Research Site

Middleburg Heights, Ohio, 44130, United States

Location

Clinical Research Site

Austin, Texas, 78737, United States

Location

Clinical Research Site

Cypress, Texas, 77429, United States

Location

Clinical Research Site

Mesquite, Texas, 75149, United States

Location

Clinical Research Site

San Antonio, Texas, 78229, United States

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Clinical Research Site

Sugar Land, Texas, 77478, United States

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Clinical Research Site

Rutland, Vermont, 05701, United States

Location

Clinical Research Site

Arlington, Virginia, 22205, United States

Location

Clinical Research Site

Bayamón, 00961, Puerto Rico

Location

Clinical Research Site

San Juan, 00918, Puerto Rico

Location

Related Links

MeSH Terms

Conditions

Alzheimer DiseasePsychomotor Agitation

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersDyskinesiasNeurologic ManifestationsPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2022

First Posted

September 28, 2022

Study Start

September 6, 2022

Primary Completion

November 21, 2024

Study Completion

December 21, 2024

Last Updated

November 26, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(53)PR(2)