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frequently asked questions

ABOUT RESEARCH STUDIES

What is a research study?

    • A research study tests new drugs, new medical devices, new surgical procedures, and other things that affect human health.
    • The START Study is a research study testing whether the study drug (CT1812) can help slow memory loss caused by Alzheimer’s disease (AD).
    • Every investigational drug goes through the research study process. Participants are given specific medical treatments and researchers closely watch the results to help decide if the drug should be approved for wider use.
    • People in the study play a very important role in advancing medicine for others

Who leads research studies?
To help make sure a research study is ethical and that your rights are protected, in the U.S. an Institutional Review Board (IRB) reviews and approves rules on how the study is run. There are also teams who visit the study sites to make sure the study is being run in the correct way, according to the approved rules.

Why is diversity important?
If a study does not include people of diverse backgrounds, we cannot know for sure if a study drug works for everyone. Studies only show if a drug works for the people who are in that study. It might not work the same in people of different races, ethnicities, ages, or sexes if not tested within these groups.

What is a study drug?
A study drug is not yet approved for sale by any government health agency or authority. Clinical research studies, also called trials, are used to test the safety and effectiveness of a study drug.

ABOUT THE START STUDY

Why is the START Study important?
Scientists are always looking for better ways to treat Alzheimer’s disease. Trials like the START Study are an important part of this process. If you join the START Study, you will be helping researchers figure out if the study drug might be an effective treatment option for people with Alzheimer’s disease.

How do researchers decide who can be in the START Study?
Researchers use a careful screening process to evaluate people for the START Study. All studies have rules that determine eligibility. Some of these rules include:

    • age
    • other health conditions
    • current medications
    • participant location

The study site can give you more information about who can or cannot be in this study. You and your study partner will have time to ask any questions you may have before deciding to participate.

Find a Location or call 1-833-START-33 (1-833-782-7833)

How can I see if I qualify for the START Study?
As a first step, visit the Study Locations page to find the study site closest to you. Each site has contact information so you can talk to someone who can help determine if you qualify for the START Study.

Find a Location or call 1-833-START-33 (1-833-782-7833)

If I join the START Study, will I get the study drug?
In the START Study, some participants will receive a placebo. A placebo is a pill that looks just like the study drug but does not have any active drug. The people who get the placebo are chosen at random. Study participants, their study partners, and the staff at the study site will not know whether the participant is receiving the study drug or the placebo.

What is the length of the START Study? 
The study lasts about two years and includes a Screening Period that can last up to 3 months, when doctors do tests to see if you are eligible to be in the study. This is followed by the Treatment Period, which is 18 months long. There is a final visit one month after the Treatment Period.

What do I have to do while in the START Study?

    • You and your study partner are asked to follow the rules and instructions listed on the Informed Consent Form for the START Study.
    • To protect your health as much as possible, the START Study will be run by trained people under the direct supervision of the study doctor. You or your study partner will need to give all information about your past and current health during the Screening Period.
    • You will be asked about any changes to your health at each study visit. This includes letting your research site know if you are in any other study at the same time you are in this one.
    • If you or the person in the START Study has a primary care doctor, you should let him or her know you may want to be in this research study.

Does my study partner have to attend every visit with me?
Your study partner will need to attend some study visits and share information about you to make sure all the data we gather is correct and complete.

If I join the START Study and change my mind, can I quit?
Yes. Participation in the START Study is voluntary and a person in the study may stop participation at any time.

Tell your START Study doctor if you or your loved one are thinking about stopping or decide to stop. You should talk to the study doctor about leaving the START Study before the decision is made so the doctor can find out if you or your loved one are having any side effects from study treatment, and can explain how to safely stop taking the study drug (or placebo).

RISKS AND BENEFITS

What are some of the risks and benefits of being in the START Study?
Some possible risks of being in the START Study are:

    • The study drug may not help you.
    • You may have side effects from the study drug. Not all side effects of a study drug can be predicted, but researchers and Institutional Review Boards (IRBs) do their best to make sure they keep the risks low.
    • You will have medical tests that may be uncomfortable, such as blood draws or lumbar punctures.

Some possible benefits of being in the study are:

    • You will help researchers learn more about how the study drug affects people like you.
    • Your health will be watched by the trial doctors and nurses.

How do I know the study drug is safe?

    • The FDA works to protect people in clinical studies and to make sure they have good information before deciding whether to join a study.
    • The U.S. government has rules and guidelines for this type of research to protect people in a study from too much risk.
    • Monitors at each study site ensure that IP administration and safety is being adhered to.
    • Efforts are made to control risks, though some risks may be unavoidable because we are still learning about the study drug.

The START Study is a Phase 2 study. Your study team will review the risks and benefits of the START Study and of CT1812 with you before you decide to be in the study or not.

 

Will my identity stay private? 

    • Yes. Federal law requires that we keep your health and personal information private, so there are security steps we take to protect every person’s personal information.
    • These steps are in place to stop anyone’s personal information from getting lost, used, changed, shared, or accessed in any way that isn’t permitted. To protect the identity of each person in the study, his or her personal information will be coded with its own study number.
    • More information about how we protect your privacy will be shared with anyone who choose to participate in the study at your study site location.
MY CURRENT TREATMENT

Can I continue to see my primary care doctor and my other doctors?
Yes, in fact you are encouraged to continue seeing your regular doctors. While in the study, you will also get a high standard of care from the study doctors and study staff.

Should I tell my other doctors I am in a study?
Yes, you should let your other doctors know that you are in a study. If not, they may prescribe medications or other treatments that are not allowed during the START Study. Your study team can help you contact your other doctors and make sure your medical care continues.

Can I qualify for the START Study if I have other medical problems?
It is possible. Even if you have a condition like heart disease or diabetes, you may still be able to take part in the START Study. The staff at the study site can help you figure out if you qualify for the START Study.

Can I keep taking my other medications that are not for Alzheimer’s disease, like diabetes or blood pressure medications? 
Maybe. If you decide to screen for the START Study, the study team will go over all of your medications and let you know if they are allowed or not. This may change your mind about wanting to be in the study, and that’s okay. Screening for the START Study does not mean you must be in the study.