Assessing Clinical Outcomes in Alzheimer's Disease Agitation

Phase 3

Completed

• Conditions: Agitation in Patients With Dementia of the Alzheimer's Type; Alzheimer Disease; Agitation,Psychomotor
• Interventions: Drug: AXS-05; Drug: Placebo

• Registration Number: NCT04797715
• Lead Sponsor: Axsome Therapeutics, Inc.

Brief Summary

This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated with Alzheimer's disease.

Detailed Description

Enrolled patients will first enter a 9-week, open-label stabilization period, during which they will be treated with AXS-05 and monitored for a treatment response. Patients who experience a treatment response during the stabilization period will then be randomized into the double-blind treatment period, in a 1:1 ratio, to continue treatment with AXS-05 or to switch to placebo, for up to 26 weeks or until a relapse of agitation occurs.

Study Timeline

• Study Start: 2020-12-31
• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-15
• Primary Completion: 2022-11-21
• Study Completion: 2022-11-21
• Status Verified: 2023-11
• Disposition First Submitted: 2023-11-20
• Last Update Submitted: 2023-11-27
• Disposition First Posted: 2023-11-29
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AXS-05	AXS-05	Up to 26 weeks in double-blind period
Placebo	Placebo	Up to 26 weeks in double-blind period

Primary Outcome Measures

Name	Time	Method
Time from randomization to relapse of agitation symptoms	up to 26 weeks

Trial Locations

Locations (1)

Clinical Research Site; 🇨🇦 Newmarket, Ontario, Canada