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

Testing AXS-05 for Alzheimer's agitation safety and effectiveness.

Recruiting
65-90 years
All
Phase 3

This study is testing a new medicine called **AXS-05** to see if it helps with **agitation** (feeling restless or upset) in people with **Alzheimer's disease**, a brain condition that affects memory and thinking. The study will compare AXS-05 to a **placebo**, which is a pill that looks the same but doesn't have medicine. People in the study will not know which one they are taking, making it a **double-blind** study. The study will last up to 5 weeks.

To join, you need to have been diagnosed with Alzheimer's disease and have noticeable agitation. If you have a different kind of dementia or can't follow study rules, you can't join. The study takes place at different locations (**multi-center**), and participants will be chosen randomly (**randomized**) to get either AXS-05 or placebo.

  • Study Duration: Up to 5 weeks
  • No cost for the medication
  • Potential benefits include reduced agitation symptoms

Talk to your doctor if you are interested in joining or want more information about the risks and benefits.

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

NCT05557409

Axsome Therapeutics, Inc.

12 October 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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