← Trials/Trial dossier/NCT06736509

TerminatedPhase 3Results posted

An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study

Lead sponsor

Axsome Therapeutics, Inc.

Asset

AXS-05

Listed sites

Recruiting sites

Enrollment

139

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Long-Term Safety

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-305

NCT IDNCT06736509

Timeline

Milestones

Study start2024-11-21actual

Study first posted2024-12-16actual

Primary completion2025-02-17actual

Study completion2025-04-25actual

Last update posted2026-06-25actual

Results first posted2026-06-25actual

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

•Completed the treatment period in Study AXS-05-AD-304 or exited from Study AXS-05-AD-303 due to study completion.

•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-304 and/or AXS-05-AD-303 which may pose a safety risk when taken concurrently with AXS-05.

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.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Long-Term Safety

Time frame:Up to 25 weeks

event count, event

Primary/registry result

Long-Term Safety

Time frame:Up to 25 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Open-LabelSubjects with any TEAEsn=139 Participants	16	-
Subjects with suspected to be drug-related TEAEsn=139 Participants	7	-
Subjects with serious TEAEsn=139 Participants	0	-
Subjects with TEAEs that led to drug withdrawaln=139 Participants	0	-
Subjects with TEAEs that led to study discontinuationn=139 Participants	0	-
Subjects with TEAEs that resulted in deathn=139 Participants	0	-
Subjects with no TEAEsn=139 Participants	116	-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

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.