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

Phase 3

Active, not recruiting

• Conditions: Agitation in Patients with Dementia of the Alzheimer's Type; Alzheimer Disease; Agitation, Psychomotor
• Interventions: Drug: AXS-05 (dextromethorphan-bupropion); Drug: Placebo

• Registration Number: NCT04947553
• Lead Sponsor: Axsome Therapeutics, Inc.

Brief Summary

This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.

Detailed Description

This study is a multi-center trial consisting of an open-label segment of up to 52 weeks, followed by a double-blind, placebo-controlled, randomized withdrawal segment. Subjects participating in the randomized-withdrawal segment will be randomized in a 1:1 ratio either to continue to receive AXS-05 or switch to placebo, for up to 24 weeks.

Study Timeline

• Study Start: 2021-06-17
• Study First Submitted: 2021-06-24
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-07-01
• Status Verified: 2024-12
• Primary Completion: 2024-12
• Study Completion: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AXS-05 (dextromethorphan-bupropion)	AXS-05 (dextromethorphan-bupropion)	* Up to 52 weeks in the open-label segment; * Up to 24 weeks in the randomized double-blind segment (if applicable)
Placebo	Placebo	Up to 24 weeks in the randomized double-blind segment (if applicable)

Primary Outcome Measures

Name	Time	Method
Long-term Safety	up to 76 weeks	Incidence of treatment-emergent adverse events following dosing with AXS-05
Time to relapse of agitation symptoms	up to 24 weeks

Trial Locations

Locations (1)

Clinical Research Site; 🇵🇷 San Juan, Puerto Rico