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NCT04947553 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Alzheimer Disease and Agitation in Patients With Dementia of the Alzheimer's Type, sponsored by Axsome Therapeutics.

Completed
Registry status
Phase 3
Development phase
456
Enrollment target
20
Study locations

NCT04947553 is a Phase 3 study of Alzheimer Disease and Agitation in Patients With Dementia of the Alzheimer's Type that has completed, run by Axsome Therapeutics. The registered enrollment target is 456 participants, below the 2,749-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 3 states.

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The verdict

NCT04947553, a Phase 3 study of Alzheimer Disease and Agitation in Patients With Dementia of the Alzheimer's Type, has completed, sponsored by Axsome Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
456 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.

Conditions Studied

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

Interventions

  • DRUG Placebo
  • DRUG AXS-05 (dextromethorphan-bupropion)

Study Locations (20)

Florida

  • Clinical Research Site - Bonita Springs
  • Clinical Research Site - Brandon
  • Clinical Research Site - Coral Springs
  • Clinical Research Site - Greenacres City
  • Clinical Research Site - Hialeah
  • Clinical Research Site - Hollywood
  • Clinical Research Site - Kissimmee
  • Clinical Research Site - Lake City
  • Clinical Research Site - Miami
  • Clinical Research Site - Miami
  • Clinical Research Site - Miami
  • Clinical Research Site - Miami
  • Clinical Research Site - Miami
  • Clinical Research Site - Miami

California

  • Clinical Research Site - Long Beach
  • Clinical Research Site - Santa Ana
  • Clinical Research Site - Temecula
  • Clinical Research Site - Walnut Creek

Arizona

  • Clinical Research Site - Peoria
  • Clinical Research Site - Tempe

Trial Details

FieldValue
Enrollment Target 456 participants
Start Date 2021-06-17
Est. Completion 2024-12-21
Phase Phase 3

Sponsor

Axsome Therapeutics

28 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04947553

The ClinicalTrials.gov registry entry for NCT04947553 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 456 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,749-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (83% lower). The listed sponsor is Axsome Therapeutics, which has 28 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04947553 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT04947553 about?

NCT04947553 is a clinical study titled "A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation". This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.

What is the current status of trial NCT04947553?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 456 participants. The study started on 2021-06-17. Estimated completion is 2024-12-21.

What conditions does trial NCT04947553 study?

This clinical trial studies the following conditions: Alzheimer Disease, Agitation in Patients With Dementia of the Alzheimer's Type, Agitation, Psychomotor.

What interventions are being tested in trial NCT04947553?

The interventions under investigation include: Placebo (DRUG), AXS-05 (dextromethorphan-bupropion) (DRUG).

Who is sponsoring clinical trial NCT04947553?

This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04947553 being conducted?

This trial has 20 study locations across Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.