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NCT04797715 · ClinicalTrials.gov registry record · Phase 3

Assessing Clinical Outcomes in Alzheimer's Disease Agitation

A Phase 3 study, sponsored by Axsome Therapeutics.

Completed
Registry status
Phase 3
Development phase
178
Enrollment target

NCT04797715 is a Phase 3 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 178 participants.

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The verdict

NCT04797715, a Phase 3 study, has completed, sponsored by Axsome Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
178 participants
Enrollment target

Study Summary

This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated with Alzheimer's disease.

Interventions

  • DRUG Placebo
  • DRUG AXS-05

Trial Details

FieldValue
Enrollment Target 178 participants
Start Date 2020-12-31
Est. Completion 2022-11-21
Phase Phase 3

Sponsor

Axsome Therapeutics

28 total trials

What the Registry Record Tells You About NCT04797715

The ClinicalTrials.gov registry entry for NCT04797715 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 178 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.

NCT04797715 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04797715 about?

NCT04797715 is a clinical study titled "Assessing Clinical Outcomes in Alzheimer's Disease Agitation". This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated with Alzheimer's disease.

What is the current status of trial NCT04797715?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 178 participants. The study started on 2020-12-31. Estimated completion is 2022-11-21.

What interventions are being tested in trial NCT04797715?

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

Who is sponsoring clinical trial NCT04797715?

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.