Addressing Dementia Via Agitation-Centered Evaluation (ADVANCE)

Axsome Therapeutics

Status and phase: Completed; Phase 3; Phase 2

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

Treatments: Drug: Placebo; Drug: Bupropion; Drug: AXS-05

Study type: Interventional

Funder types: Industry

Identifiers

NCT03226522

AXS-05-AD-301

Details and patient eligibility

About

This is a multi-center, randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's disease.

Enrollment: 366 patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.
• 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

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366 participants in 3 patient groups, including a placebo group

AXS-05

Experimental group

Description:

AXS-05 tablets taken by mouth for 5 weeks.

Treatment:

Drug: AXS-05

Bupropion

Active Comparator group

Description:

Bupropion tablets taken by mouth for 5 weeks.

Treatment:

Drug: Bupropion

Placebo

Placebo Comparator group

Description:

Placebo tablets taken by mouth for 5 weeks.

Treatment:

Drug: Placebo