MINDSET Study

What do Participants Do?: Attend a study-screening visit to determine eligibility for the study; Read and sign a consent form; Come to the study center for 9 study visits (including the study-screening visit) over a 33-week period to assess health and/or study drug effects; Continue to take donepezil throughout the course of the study. It will be provided to you free of charge.; Take the investigational drug or placebo for up to 24 weeks. It will also be provided to you free of charge. The medication is a tablet that is taken once a day, with or without food. All participants who complete the study will be eligible to continue into a 12-month open-label extension study where all participants will receive the investigational medication.; Bring a study partner or caregiver to answer questions asked about how you are doing

What do Study participants receive?: Study-related monitoring from study physicians and medical teams experienced in Alzheimer’s disease; All study‐related exams and tests; The opportunity to receive the investigational drug; Donepezil, provided to all study participants at no cost; Transportation assistance or travel reimbursement. Compensation for study-related time may also be provided.

Why is this Study Important?: MINDSET is a Phase III clinical research program evaluating an investigational medication, RVT-101, for mild-to-moderate Alzheimer’s disease. It has already been tested in 13 clinical trials, including a 684-subject study where it was found to have statistically significant benefits on cognition and ability to perform daily tasks as compared to donepezil alone. The MINDSET study aims to confirm these results. If approved, this will be the first new Alzheimer’s drug on the market in 17 years. It is important to have African Americans participating in this trial to make sure it is both safe and effective for us. African Americans are at least twice as likely to develop Alzheimer’s as White Americans, yet we are significantly underrepresented in clinical research. Only 5 percent of research participants are African Americans despite being over 13 percent of the population. To ensure that treatments work for everyone, everyone must participate!

What are the study facts?: Study participation is voluntary.; All information is confidential.; There is no cost to the family.; Study participants can continue to see their regular doctor(s) while participating in MINDSET; Medical insurance is not required to participate; A participant may withdraw from the study at any time.; The Mindset study lasts for 33 weeks (a little over six months) and participants will be required to visit the research site 9 times. All participants who complete the study will be eligible to continue into a 12-month open-label extension study where all participants will receive the investigational medication.; Transportation assistance or travel reimbursement will be provided to study participation. Compensation for study-related time may also be provided.

Who can join the Study?: Are 50 to 85 years old with a clinical diagnosis of mild to moderate Alzheimer’s disease (AD); Have been taking donepezil for at least 4 months for AD; Have an MMSE score 12 to 24; Have a study partner or caregiver (someone who has regular contact with you, is willing to come with you to your 9 office visits, and able to answer questions about how you are doing.

**Additional eligibility criteria apply

Who is sponsoring the study?: The MINDSET study is being sponsored by Axovant Sciences, Inc. and is currently offered in 43 local research sites throughout the United States.

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