Frequently Asked Questions

Clinical research studies are designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing medications. Studies are important for medical research advances. Current treatments for diseases and conditions are only available because of study volunteers.

Learn more about clinical studies at: www.nimh.nih.gov/health/trials/index.html

An investigational medication is a substance that is being tested in clinical research studies that is not approved by the Food and Drug Administration for treatment of this condition.

A placebo looks like the investigational medication but has no active medication in it. Researchers compare the results of the investigational medication to those of the placebo.

Research studies are typically conducted by a trained medical professional. An Institutional Review Board (IRB) reviews all research studies. This is a committee made up of doctors, ethicists, and members of the general public and administrators. This group helps to ensure that the rights of research participants are protected. A participant’s regular doctor is responsible for their well-being and they may want to speak with their doctor before agreeing to participate in a study as there are possible risks associated with participation. Whenever someone agrees to enter a study, they are given the name and telephone number of a contact in their study physician's office who will answer their questions as well as a contact for the institutional review board overseeing the study, whom they can contact if they have questions or concerns.

If someone has been diagnosed with Alzheimer’s disease, are currently experiencing restlessness, aggression or irritability, and are between the ages of 65-90 years, they may be eligible to participate in the ACCORD study. The ACCORD study is for people that are living with dementia from Alzheimer’s or are taking medications for Alzheimer’s disease and who are showing signs of restlessness, aggression or irritability. A caregiver’s participation and attendance at regular study visits is also required. If someone you know or provide care for qualifies, the research site will explain all the study procedures thoroughly to you.

Participation in this study could last up to 39 weeks, or almost 10 months. The study is divided into three periods:

• Screening period (up to 4 weeks)
• Period 1 (up to 9 weeks)
• Period 2 (up to 26 weeks)

After a short screening period, participants who choose to take part in the ACCORD study will take an investigational medication (AXS-05, not placebo) for up to 9 weeks. If there is a treatment response (their restlessness, aggression or irritability gets better), they can go into the next part of the study where they have an equal chance (50/50) of taking the investigational medication or a placebo for up to 26 weeks.

Participants will meet with the study team 38 times during the screening and treatment periods. 22 of these meetings may happen remotely.

There may be medications someone you know or provide care for is currently taking that are exclusionary. There may also be certain allowed medications. If you qualify for a screening visit, please bring the full list for discussion with the research physician and the study team.

Participants will be expected to take the investigational medication (or placebo) by mouth twice a day during the treatment period (up to 35 weeks). Lab tests, a physical exam, and other assessments and questionnaires will be conducted at study visits, but not all activities will occur at every visit.

After finishing the study, participants will have the option to join another study in which they will be given the investigational drug (AXS-05, not placebo) for up to 6 months. The purpose of this other study is to see if the investigational medication helps participants’ symptoms of restlessness, aggression or irritability over a longer treatment time.

Participants do not have to pay for participation in a clinical research study. This includes the investigational medication, study supplies, study visits, or any tests that are part of the study. They may receive reimbursement for their time and travel.

There are possible risks involved with any clinical research study. The study doctor will review the risks with participants, and they will be closely monitored throughout the study. They may experience side effects and be uncomfortable, the investigational medication may not work for them, or it may not be better than their current treatment, and they may not be part of the treatment group that gets the investigational medication in Period 2.

Confidentiality is an important part of clinical research studies. Their personal information will be seen only by those authorized to have access.