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ACCORD-2

CompletedPhase 3

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

An Open-Label and Double-Blind, Randomized Withdrawal Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Dementia of the Alzheimer's Type

Asset

AXS-05

Listed sites

47

Recruiting sites

-

Enrollment

456

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoints

•Long-term Safety•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-303
NCT IDNCT04947553

Timeline

Milestones

Study start2021-06-17actual
Study first posted2021-07-01actual
Primary completion2024-12-03actual
Study completion2024-12-21actual
Last update posted2025-12-08actual

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

•Participation in Study AXS-05-AD-302 or Study AXS-05-AD-304.
•Caregiver is willing to communicate with site personnel, comply with all required study procedures, and oversee administration and compliance with the subject's study treatment

Exclusion criteria

•Caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions.
•Subject is hospitalized in a mental health facility (e.g., psychiatric hospital or ward), living in a nursing home, or living alone.
•Any concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or endanger the subject's well-being.
•Initiation of a new medication since enrolling in AXS-05-AD-302 or AXS-05-AD-304 which may pose a safety risk when taken concurrently with AXS-05.

Endpoints (3)

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
2
Safety / tolerability / PK
1

Behavior / neuropsychiatric

2 endpoints
Primary/protocol endpoint

Time to relapse of agitation symptoms

Time frame:up to 24 weeks

time to event, event

Other/protocol endpoint

Cohen-Mansfield Agitation Inventory (CMAI)

Time frame:up to 76 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Long-term Safety

Time frame:up to 76 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.