Addressing Dementia Via Agitation-Centered Evaluation

• Status: Completed
• Trial end date: 2020-04-17
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axsome Therapeutics, Inc.
• Treatments: Bupropion

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.