Assessing Clinical Outcomes in Alzheimer's Disease Agitation

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04797715

Acronym

ACCORD

Enrollment

178

Registered

2021-03-15

Start date

2020-12-31

Completion date

2022-11-21

Last updated

2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DRUGAXS-05

AXS-05 tablets, taken twice daily

DRUGPlacebo

Placebo tablets, taken twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to 90 Years

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.

Design outcomes

Primary

Measure	Time frame
Time from randomization to relapse of agitation symptoms	up to 26 weeks

Other

Measure	Time frame
Types and rates of adverse events	up to 35 weeks

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026