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FREQUENTLY ASKED QUESTIONS

To participate in these trials, one must:

  • Be ages 50 to 87 years old
  • Be diagnosed with, or have a suspected clinical diagnosis of, Alzheimer’s disease
  • Have a gradual change in memory for six months or more
  • Have someone available as a study partner during the entire trial
  • Be fully vaccinated for COVID-19 or have had a previous COVID-19 infection
  • Be able and willing to participate for 62 or 86 weeks

There are additional criteria that are reviewed by the study team during your first appointment.

You and/or your study partner will meet with a study coordinator at a study site location closest to you. You will learn more about the research, the trial and the benefits and risks of participation in a trial.

The study coordinator or study doctor will discuss an Informed Consent Form with you . Informed Consent involves providing you with adequate information to allow for an informed decision about participation in the RethinkALZ or RefocusALZ trials. The process will provide sufficient opportunity for you to ask questions and to consider whether to participate. This process will occur under circumstances that minimize the possibility of coercion or undue influence. If you are comfortable with the information provided and the answers to your questions, you will be asked to sign the Informed Consent Form allowing you to participate in the RethinkALZ or RefocusALZ trials.

Different procedures will be performed to see if you qualify for the clinical study. You and your study partner will also be asked questions about your health history and your memory.

  • The RethinkALZ or RefocusALZ trials are researching a new drug candidate called simufilam. Simufilam comes in a small, tasteless pill that is taken by mouth twice-a-day. Doctors and researchers want to test if simufilam is safe and effective for slowing down the progression of Alzheimer’s disease.

You will be asked to take the study drug or placebo twice a day for 52 weeks or 76 weeks.

You and your study partner will return to the study center about every 3 months. At these appointments, the study team will ask you questions about your health history and memory. They will also perform study procedures to evaluate your wellbeing, including physical exams and taking vital signs.

The study drug (simufilam) is a new drug candidate. It is not approved for the treatment of any health condition anywhere in the world.

Study centers for the RethinkALZ or RefocusALZ trials are located across the United States and Canada. In the future, study centers may be added in other locations.

You do not have to stop taking your medication unless you are advised to do so by the study center staff or your primary care physician.

  • No – there will be no cost to you or loved ones for participating in the RethinkALZ or RefocusALZ trials.
  • No, health insurance is not a requirement to participate in the RethinkALZ or RefocusALZ trials.

Clinical Research Studies

Clinical trials, also known as clinical studies or research studies are conducted by doctors and researchers to see if new medications or treatments are safe and effective before being approved for use by the general public. For basic information about clinical trials, please visit: https://www.fda.gov/patients/clinical-trials-what-patients-need-know/basics-about-clinical-trials.

Research studies are used to test new medications for safety, tolerability, and effectiveness before they are approved for use by the public.

You can find out more information about clinical trials by browsing through www.clinicaltrials.gov. This is an online, government database that is managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research studies.

All research studies require that doctors and/or researchers give interested participants complete and accurate information about the risks, benefits and activities of a research study. Informed Consent involves providing you with adequate information to allow for an informed decision about participation in the RethinkALZ or RefocusALZ trials. The process will provide sufficient opportunity for you to ask questions and to consider whether to participate. This process will occur under circumstances that minimize the possibility of coercion or undue influence. If you are comfortable with the information provided and the answers to your questions, you will be asked to sign the Informed Consent Form allowing you to participate in the RethinkALZ or RefocusALZ trials.