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Completed Phase 2Phase 3 Interventional Results available

Addressing Dementia Via Agitation-Centered Evaluation

ClinicalTrials.gov ID: NCT03226522

Public ClinicalTrials.gov record NCT03226522. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 2:57 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a multi-center, randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's disease.

Study identification

NCT ID
NCT03226522
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Enrollment
366 participants

Conditions and interventions

Eligibility (public fields only)

Age range
65 Years to 90 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 12, 2017
Primary completion
Apr 16, 2020
Completion
Apr 16, 2020
Last update posted
Sep 12, 2023

2017 – 2020

United States locations

U.S. sites
77
U.S. states
25
U.S. cities
70
Facility City State ZIP Site status
Axsome Study Site Gilbert Arizona 85297
Axsome Study Site Phoenix Arizona 85004
Axsome study site Scottsdale Arizona 85251
Axsome study site Scottsdale Arizona 85258
Axsome Study Site Tucson Arizona 85704
Axsome Study Site Little Rock Arkansas 72209
Axsome study site Canoga Park California 91303
Axsome study site Costa Mesa California 92626
Axsome study site Fresno California 93710
Axsome study site Long Beach California 90806
Axsome study site Long Beach California 90807
Axsome Study Site Los Alamitos California 90720
Axsome study site Riverside California 92503
Axsome study site Sacramento California 95821
Axsome study site Santa Ana California 92705
Axsome Study Site Santa Clarita California 91321
Axsome study site Sherman Oaks California 91403
Axsome study site Simi Valley California 93065
Axsome study site Temecula California 92591
Axsome study site Ventura California 93003
Axsome Study Site Colorado Springs Colorado 80910
Axsome study site Cromwell Connecticut 06416
Axsome study site New London Connecticut 06320
Axsome Study Site Apopka Florida 32703
Axsome study site Boca Raton Florida 33487
Axsome study site Boynton Beach Florida 33437
Axsome Study Site Coconut Creek Florida 33066
Axsome Study Site Greenacres City Florida 33467
Axsome study site Hallandale Florida 33009
Axsome study site Hialeah Florida 33012
Axsome Study Site Lake City Florida 32055
Axsome study site Miami Florida 33122
Axsome study site Miami Florida 33165
Axsome Study Site Orlando Florida 32807
Axsome study site Pensacola Florida 32502
Axsome Study Site Port Orange Florida 32127
Axsome study site Spring Hill Florida 34609
Axsome study site Tampa Florida 33609
Axsome study site Tampa Florida 33613
Axsome study site Atlanta Georgia 30331
Axsome study site Decatur Georgia 30030
Axsome Study Site Honolulu Hawaii 96817
Axsome study site Boise Idaho 83704
Axsome Study Site Flossmoor Illinois 60422
Axsome study site Avon Indiana 46123
Axsome Study Site Overland Park Kansas 66212
Axsome Study Site Topeka Kansas 66606
Axsome study site Baton Rouge Louisiana 70808
Axsome Study Site Lake Charles Louisiana 70629
Axsome Study Site Hattiesburg Mississippi 39401
Axsome study site Chesterfield Missouri 63005
Axsome Study Site St Louis Missouri 63128
Axsome study site Las Vegas Nevada 89102
Axsome Study Site Las Vegas Nevada 89109
Axsome Study Site Princeton New Jersey 08540
Axsome study site Toms River New Jersey 08755
Axsome Study Site Albany New York 12208
Axsome study site Brooklyn New York 11229
Axsome study site New York New York 10036
Axsome study site New York New York 10128
Axsome study site Staten Island New York 10312
Axsome Study Site Charlotte North Carolina 28211
Axsome study site Charlotte North Carolina 28270
Axsome Study Site Winston-Salem North Carolina 27103
Axsome study site Cincinnati Ohio 45069
Axsome Study Site Dayton Ohio 45459
Axsome study site Shaker Heights Ohio 44122
Axsome Study Site Oklahoma City Oklahoma 73112
Axsome study site DeSoto Texas 75115
Axsome Study Site McKinney Texas 75071
Axsome study site Wichita Falls Texas 76309
Axsome study site Orem Utah 84058
Axsome Study Site Charlottesville Virginia 22903
Axsome Study Site Richmond Virginia 23235
Axsome study site Bellevue Washington 98007
Axsome Study Site Everett Washington 98201
Axsome study site Spokane Washington 99202

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03226522, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 12, 2023 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03226522 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →