Assessing Clinical Outcomes in Alzheimer's Disease Agitation

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type

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

Intervention / Treatment
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* Drug: AXS-05
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AXS-05<br>Up to 26 weeks in double-blind period | Drug: AXS-05<br>* AXS-05 tablets, taken twice daily<br>|
| Placebo Comparator: Placebo<br>Up to 26 weeks in double-blind period | Drug: Placebo<br>* Placebo tablets, taken twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from randomization to relapse of agitation symptoms |  | up to 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Axsome, AD agitation, AXS-05, NMDA receptor antagonist, dextromethorphan, bupropion, ACCORD