Assessing Clinical Outcomes in Alzheimer's Disease Agitation

NCT04797715 | Completed Phase 3 FDA Drug

• 1 other identifier: AXS-05-AD-302
• Study Type: interventional
• Target: 178
• Locations: 2 countries
• Sites: 63

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.

Conditions

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

Keywords

AD agitation; AXS-05; NMDA receptor antagonist; dextromethorphan; bupropion; Axsome; ACCORD

Outcome Measures

Primary Outcomes (1)

• Time from randomization to relapse of agitation symptoms

  up to 26 weeks

Other Outcomes (1)

• Types and rates of adverse events

  up to 35 weeks

Study Arms (2)

AXS-05

EXPERIMENTAL

Up to 26 weeks in double-blind period

Drug: AXS-05

Placebo

PLACEBO COMPARATOR

Up to 26 weeks in double-blind period

Drug: Placebo

Interventions

AXS-05 DRUG

AXS-05 tablets, taken twice daily

AXS-05

Placebo DRUG

Placebo tablets, taken twice daily

Placebo

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Axsome Therapeutics, Inc.: lead

Study Sites (63)

Clinical Research Site

Sun City, Arizona, 85351, United States

Location

Clinical Research Site

Tucson, Arizona, 85710, United States

Location

Clinical Research Site

Chula Vista, California, 91910, United States

Location

Clinical Research Site

Imperial, California, 92251, United States

Location

Clinical Research Site

Lafayette, California, 94549, United States

Location

Clinical Research Site

Los Alamitos, California, 90720, United States

Location

Clinical Research Site

Los Angeles, California, 90064, United States

Location

Clinical Research Site

Oceanside, California, 92056, United States

Location

Clinical Research Site

San Diego, California, 92103, United States

Location

Clinical Research Site

Santa Ana, California, 92705, United States

Location

Clinical Research Site

Temecula, California, 92591, United States

Location

Clinical Research Site

Coral Springs, Florida, 33067, United States

Location

Clinical Research Site

Hialeah, Florida, 33012, United States

Location

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Kissimmee, Florida, 34741, United States

Location

Clinical Research Site

Lake City, Florida, 32055, United States

Location

Clinical Research Site

Miami, Florida, 33155, United States

Location

Clinical Research Site

Miami, Florida, 33175, United States

Location

Clinical Research Site

Miami, Florida, 48532, United States

Location

Clinical Research Site

Miami Lakes, Florida, 33014, United States

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Clinical Research Site

Naples, Florida, 34105, United States

Location

Clinical Research Site

Ocoee, Florida, 34761, United States

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Clinical Research Site

Orlando, Florida, 32807, United States

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Clinical Research Site

Orlando, Florida, 32819, United States

Location

Clinical Research Site

Pembroke Pines, Florida, 33024, United States

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Pensacola, Florida, 32502, United States

Location

Clinical Research Site

St. Petersburg, Florida, 33709, United States

Location

Clinical Research Site

Sunrise, Florida, 33351, United States

Location

Clinical Research Site

Tampa, Florida, 33634, United States

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Clinical Research Site

Trinity, Florida, 34655, United States

Location

Clinical Research Site

Augusta, Georgia, 30912, United States

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Clinical Research Site

Columbus, Georgia, 31909, United States

Location

Clinical Research Site

Suwanee, Georgia, 30024, United States

Location

Clinical Research Site

Honolulu, Hawaii, 92103, United States

Location

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Boise, Idaho, 83704, United States

Location

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Wichita, Kansas, 67214, United States

Location

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Bangor, Maine, 04401, United States

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Lowell, Massachusetts, 01852, United States

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Clinical Research Site

Flint, Michigan, 48532, United States

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Clinical Research Site

Chesterfield, Missouri, 63005, United States

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Clinical Research Site

Las Vegas, Nevada, 89106, United States

Location

Clinical Research Site

Toms River, New Jersey, 08755, United States

Location

Clinical Research Site

Brooklyn, New York, 11229, United States

Location

Clinical Research Site

East Syracuse, New York, 13057, United States

Location

Clinical Research Site

New Windsor, New York, 12553, United States

Location

Clinical Research Site

New York, New York, 10036, United States

Location

Clinical Research Site

Charlotte, North Carolina, 28211, United States

Location

Clinical Research Site

Hickory, North Carolina, 28601, United States

Location

Clinical Research Site

Dayton, Ohio, 45459, United States

Location

Clinical Research Site

Jenkintown, Pennsylvania, 19046, United States

Location

Clinical Research Site

Philadelphia, Pennsylvania, 19104, United States

Location

Clinical Research Site

Austin, Texas, 78737, United States

Location

Clinical Research Site

Cypress, Texas, 77429, United States

Location

Clinical Research Site

Houston, Texas, 77074, United States

Location

Clinical Research Site

McKinney, Texas, 75071, United States

Location

Clinical Research Site

Mesquite, Texas, 75149, United States

Location

Clinical Research Site

San Antonio, Texas, 78229, United States

Location

Clinical Research Site

Sugar Land, Texas, 77479, United States

Location

Clinical Research Site

West Jordan, Utah, 84088, United States

Location

Clinical Research Site

Woodstock, Vermont, 05091, United States

Location

Clinical Research Site

Everett, Washington, 98201, United States

Location

Clinical Research Site

Waukesha, Wisconsin, 53188, United States

Location

Clinical Research Site

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

Clinical Research Site

Newmarket, Ontario, L3Y G8, Canada

Location

Related Links

• Axsome Therapeutics Website

MeSH Terms

Conditions

Alzheimer Disease; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 15, 2021
• Study Start: December 31, 2020
• Primary Completion: November 21, 2022
• Study Completion: November 21, 2022
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (61); CA (2)