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

PHASE3CompletedINTERVENTIONAL
Enrollment

456

Participants

Timeline

Start Date

June 17, 2021

Primary Completion Date

December 3, 2024

Study Completion Date

December 21, 2024

Conditions
Agitation in Patients With Dementia of the Alzheimer's TypeAlzheimer DiseaseAgitation, Psychomotor
Interventions
DRUG

AXS-05 (dextromethorphan-bupropion)

AXS-05 tablets, taken twice daily

DRUG

Placebo

Placebo tablets, taken twice daily

Trial Locations (47)

10314

Clinical Research Site, Staten Island

11229

Clinical Research Site, Brooklyn

12553

Clinical Research Site, New Windsor

22205

Clinical Research Site, Arlington

28211

Clinical Research Site, Charlotte

28601

Clinical Research Site, Hickory

31909

Clinical Research Site, Columbus

32055

Clinical Research Site, Lake City

32807

Clinical Research Site, Orlando

33012

Clinical Research Site, Hialeah

33014

Clinical Research Site, Miami Gardens

Clinical Research Site, Miami Lakes

33024

Clinical Research Site, Hollywood

33025

Clinical Research Site, Pembroke Pines

33067

Clinical Research Site, Coral Springs

33126

Clinical Research Site, Miami

33135

Clinical Research Site, Miami

33145

Clinical Research Site, Miami

33155

Clinical Research Site, Miami

33165

Clinical Research Site, Miami

33173

Clinical Research Site, Miami

33175

Clinical Research Site, Miami

33467

Clinical Research Site, Greenacres City

33511

Clinical Research Site, Brandon

33614

Clinical Research Site, Tampa

33634

Clinical Research Site, Tampa

34134

Clinical Research Site, Bonita Springs

34655

Clinical Research Site, Trinity

34741

Clinical Research Site, Kissimmee

48307

Clinical Research Site, Rochester Hills

48532

Clinical Research Site, Flint

63005

Clinical Research Site, Chesterfield

67214

Clinical Research Site, Wichita

75149

Clinical Research Site, Mesquite

77429

Clinical Research Site, Cypress

77478

Clinical Research Site, Sugar Land

78737

Clinical Research Site, Austin

83581

Clinical Research Site, Peoria

85282

Clinical Research Site, Tempe

90807

Clinical Research Site, Long Beach

92591

Clinical Research Site, Temecula

92705

Clinical Research Site, Santa Ana

94596

Clinical Research Site, Walnut Creek

02184

Clinical Research Site, Braintree

08755

Clinical Research Site, Toms River

V1Y 1Z9

Clinical Research Site, Kelowna

00918

Clinical Research Site, San Juan

Sponsors
All Listed Sponsors
lead

Axsome Therapeutics, Inc.

INDUSTRY

NCT04947553 - A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation | Biotech Hunter | Biotech Hunter