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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

NCT06736509 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2026-02-19

No results posted yet for this study

Summary

The primary objective of this open-label extension trial is to evaluate the long-term safety of AXS-05 for the treatment of Alzheimer's disease agitation in subjects that participated in ADVANCE-2 and ACCORD-2.

Conditions

  • Agitation in Patients With Dementia of the Alzheimer's Type
  • Alzheimer Disease
  • Agitation, Psychomotor

Interventions

DRUG

AXS-05 (dextromethorphan-bupropion)

AXS-05 tablets, taken twice daily

Sponsors & Collaborators

  • Axsome Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-21
Primary Completion
2025-02-17
Completion
2025-04-25
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06736509 on ClinicalTrials.gov