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A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation (ADVANCE-2)

Axsome Therapeutics logo

Axsome Therapeutics

Status and phase

Enrolling
Phase 3

Conditions

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

Treatments

Drug: Placebo
Drug: AXS-05

Study type

Interventional

Funder types

Industry

Identifiers

NCT05557409
AXS-05-AD-304

Details and patient eligibility

About

This trial is a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of agitation associated with Alzheimer's disease.

Full description

Eligible subjects will be randomized in a 1:1 ratio for up to 5 weeks to be treated with AXS-05 or placebo.

Enrollment

350 estimated 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 significant 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.
  • Unable to comply with study procedures.
  • Medically inappropriate for study participation in the opinion of the investigator.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

350 participants in 2 patient groups, including a placebo group

AXS-05
Experimental group
Description:
Up to 5 weeks
Treatment:
Drug: AXS-05
Placebo
Placebo Comparator group
Description:
Up to 5 weeks
Treatment:
Drug: Placebo

Trial contacts and locations

53

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Central trial contact

Study Director

Data sourced from clinicaltrials.gov

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