Assessing Clinical Outcomes in Alzheimer's Disease Agitation (ACCORD)

Axsome Therapeutics

Status and phase

Completed

Phase 3

Conditions

Alzheimer Disease

Agitation,Psychomotor

Agitation in Patients With Dementia of the Alzheimer's Type

Treatments

Drug: Placebo

Drug: AXS-05

Study type

Interventional

Funder types

Industry

Identifiers

NCT04797715

AXS-05-AD-302

Details and patient eligibility

About

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.

Full 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.

Enrollment

178 patients

Sex

All

Ages

65 to 90 years old

Volunteers

No Healthy Volunteers

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.