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NCT05557409 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Axsome Therapeutics.

Completed
Registry status
Phase 3
Development phase
408
Enrollment target

NCT05557409 is a Phase 3 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 408 participants.

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The verdict

NCT05557409, a Phase 3 study, has completed, sponsored by Axsome Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
408 participants
Enrollment target

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.

Interventions

  • DRUG Placebo
  • DRUG AXS-05

Trial Details

FieldValue
Enrollment Target 408 participants
Start Date 2022-09-06
Est. Completion 2024-12-21
Phase Phase 3

Sponsor

Axsome Therapeutics

28 total trials

What the Registry Record Tells You About NCT05557409

The ClinicalTrials.gov registry entry for NCT05557409 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 408 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Axsome Therapeutics, which has 28 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05557409 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05557409 about?

NCT05557409 is a clinical study titled "A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation". 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.

What is the current status of trial NCT05557409?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 408 participants. The study started on 2022-09-06. Estimated completion is 2024-12-21.

What interventions are being tested in trial NCT05557409?

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

Who is sponsoring clinical trial NCT05557409?

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

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

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.