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Addressing Dementia Via Agitation-Centered Evaluation

NCT03226522 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2023-09-13

Study results available
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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.

Conditions

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

Interventions

DRUG

AXS-05

AXS-05

DRUG

Bupropion

Bupropion

DRUG

Placebo

Placebo

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
2017-07-13
Primary Completion
2020-04-17
Completion
2020-04-17
FDA Drug
Yes

Countries

  • United States
  • Australia

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 NCT03226522 on ClinicalTrials.gov