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

NCT05557409 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2025-11-26

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

AXS-05

AXS-05 tablets, taken twice daily

DRUG

Placebo

Placebo tablets, taken twice daily

Sponsors & Collaborators

  • Axsome Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-06
Primary Completion
2024-11-21
Completion
2024-12-21
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05557409 on ClinicalTrials.gov