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ACCORD

CompletedPhase 3

Assessing Clinical Outcomes in Alzheimer's Disease Agitation

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

Asset

AXS-05

Listed sites

63

Recruiting sites

-

Enrollment

178

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Time from randomization to relapse of agitation symptoms

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDAXS-05-AD-302
NCT IDNCT04797715

Timeline

Milestones

Study start2020-12-31actual
Study first posted2021-03-15actual
Primary completion2022-11-21actual
Study completion2022-11-21actual
Last update posted2023-11-29actual

Assets

Drug assets

AXS-05

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

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

Exclusion criteria

•Patient has dementia predominantly of non-Alzheimer's type.
•Patient has symptoms of agitation that are not secondary to AD (e.g., pain, other psychiatric disorder or delirium due to a metabolic disorder, systemic infection, or substance-induced).
•Unable to comply with study procedures.
•Medically inappropriate for study participation in the opinion of the investigator.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric
1
Safety / tolerability / PK
1

Behavior / neuropsychiatric

1 endpoint
Primary/protocol endpoint

Time from randomization to relapse of agitation symptoms

Time frame:up to 26 weeks

descriptive

Safety / tolerability / PK

1 endpoint
Other/protocol endpoint

Types and rates of adverse events

Time frame:up to 35 weeks

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.