Are you caring for someone with, or who may have Alzheimer’s disease?

Are they showing signs of restlessness, aggression, or irritability?

Researchers who are working on the ADVANCE-2 study are examining if an investigational medication may work to help these symptoms. At this time, there is no approved treatment for restlessness, aggression, or irritability associated with Alzheimer’s disease.

Does My Family Member Qualify?

About the ADVANCE-2 Study

Researchers at select research centers are looking for people who are between the ages of 65 – 90 years old, who have been diagnosed with or who may have Alzheimer’s disease and are currently showing signs of restlessness, aggression, or irritability.

The researchers are examining an investigational medication (AXS-05), which is taken orally.

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Doctors will monitor the people who participate in this study to track symptoms of the disease.

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The investigational medication’s results will be compared against a placebo, which will look like the investigational medication but have no active ingredients.

If your family member qualifies and chooses to participate, reimbursement for time and travel-related expenses may be available. There will be no cost to participate, and insurance is not required.

Who can participate in the study?

To be considered for this study, your family member must*:

Be between the ages of 65 and 90 years old,

Have been diagnosed with Alzheimer’s disease, or is showing symptoms of Alzheimer’s and

Be currently showing signs of restlessness, aggression, or irritability.

The caregiver must*:

Be a family member who has been caring for the person on a regular basis,

Be willing to attend study visits, and

Complete documents on behalf of your family member.

*please note other criteria may apply

What are some signs of restlessness, aggression, or irritability?

A few examples are listed below, but there are more.

Pacing
Aimless wandering
Swearing or using foul language
Yelling
Repetitive hand movements or mannerisms
Repeating sentences or questions
Complaining
Requesting attention or help constantly
Spitting or spitting out food when eating
Intentional falling
Hitting or hurting themselves or others
Kicking
Pushing
Grabbing onto people or things
Throwing items

How do we participate?

Complete

the online questions about your family member

Submit

your contact information

Answer

our call to answer more questions and learn about the study

Confirm

your interest and the research center location

Speak

with the research center staff about next steps to participate

Does My Family Member Qualify?

What would participating in the study involve?

If you choose to participate there are a total of 7 study visits over the course of up to 10 weeks. 6 of these visits will be at the research center and 1 visit may be done remotely as a phone call.

Screening

(approximately 4 weeks)

This is the time when the study doctor and staff determine if your family member is eligible, and you decide if you want to participate. This step can take up to 4 weeks but may be shorter.

Treatment Period

(5 weeks)

If your family member is eligible for the study, you will both enter the Study Treatment Period which lasts for 5 weeks and involves 5 visits to the site. Eligible participants enrolled into this study have an equal chance of getting either the investigational medication (AXS-05) or placebo.

During the study treatment period your family member will take the investigational medication or placebo as instructed by the study doctor. As the caregiver you will be asked to complete a daily diary and at two visits a questionnaire.

Follow Up Period

(1 week)

At Week 5 you and your family member will be given the option to enter an open-label study, where all research participants will receive the investigational medication.

If you decide you do not want to enter the open-label study you will have one final visit in the follow up period. You and your family member may be given the option to attend this final visit remotely (from home) by video or phone call.

Frequently Asked Questions

Where can I find more information about this study?

You can learn more about ADVANCE-2 by visiting ClinicalTrials.gov

About research studies

Clinical research participation is an important part of developing new treatments. In order to assess the safety and effectiveness of investigational medications, research requires people like you to take the first step. Participation in a clinical study is not a guarantee of treatment.

Why is clinical research important?

Clinical research adds to medical knowledge and helps bring new treatments to people with medical conditions. To make new treatments available to the public, they need be studied in clinical studies.

Clinical studies rely on the participation of volunteers in order to succeed.

Who runs clinical studies?

Clinical studies can be sponsored, or funded, by pharmaceutical or biotechnology companies, academic medical centers, or health care providers.

Every clinical study is led by a principal investigator, who is qualified by training and experience to conduct a clinical study. Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals.

What does it mean to participate?

Participating in a clinical study typically involves taking tests to ensure you are the right match for the study. If you qualify, you will visit the study site regularly to receive the investigational medication and complete assessments . The study site staff will monitor your progress and well-being.

Before taking part in a clinical study, you are informed about what it means to participate in the study, including how the study is conducted, how you are protected during the study and the risks and benefits of participating. You may choose to end your participation in the study at any time.

You should understand the risks and benefits of the clinical study before agreeing to participate. If you are interested in participating, please talk to your family doctor.

What is a placebo?

A placebo looks just like the investigational medication but it does not contain any active ingredients. It is often referred to as a “sugar pill.” Taking a placebo is as if the research participant was not taking anything at all.

What happens if I want to see if my family member qualifies?

There are a few steps to make sure the ADVANCE-2 study is a good fit for you and your family member.

Complete the online questions about your family member using the link and submit a phone number and email address to allow us to contact you.
If your answers indicate your family member may qualify, we’ll only use your contact information to check to see if there is a research center near you and a study representative will call you to go through some additional medical questions about your family member.
If you are still interested after talking to a study representative and it seems your family member may be eligible, your information will be sent to the research center.
The research center staff will contact you using the information you have provided to; discuss the study, answer your questions and possibly schedule an appointment.

Before officially joining the study, the researchers will explain the study in detail with you and your family member. Remember, you can choose to stop participating at any time for any reason.

Does My Family Member Qualify?