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.
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.
Doctors will monitor the people who participate in this study to track symptoms of the disease.
The investigational medication’s results will be compared against a placebo, which will look like the investigational medication but have no active ingredients.
Who can participate in the study?
To be considered for this study, your family member must*:
The caregiver must*:
*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.
- Aimless wandering
- Swearing or using foul language
- Repetitive hand movements or mannerisms
- Repeating sentences or questions
- Requesting attention or help constantly
- Spitting or spitting out food when eating
- Intentional falling
- Hitting or hurting themselves or others
- Grabbing onto people or things
- Throwing items
How do we participate?
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.
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
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
Why is clinical research important?
Clinical studies rely on the participation of volunteers in order to succeed.
Who runs clinical studies?
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?
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?
- 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.