Status:
COMPLETED
Assessing Clinical Outcomes in Alzheimer's Disease Agitation
Lead Sponsor:
Axsome Therapeutics, Inc.
Conditions:
Agitation in Patients With Dementia of the Alzheimer's Type
Alzheimer Disease
Eligibility:
All Genders
65-90 years
Phase:
PHASE3
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 subjec...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2022
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT04797715
Start Date
December 31 2020
End Date
November 21 2022
Last Update
November 29 2023
Active Locations (63)
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1
Clinical Research Site
Sun City, Arizona, United States, 85351
2
Clinical Research Site
Tucson, Arizona, United States, 85710
3
Clinical Research Site
Chula Vista, California, United States, 91910
4
Clinical Research Site
Imperial, California, United States, 92251