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At least 50 million people worldwide are thought to be living with Alzheimer’s disease (the most common form of dementia). Although the biggest risk factor for Alzheimer’s is ageing, the disease is not a normal part of getting older and there are genetic factors at play in some cases.
The goal of this study is to help develop a potential new drug treatment for Alzheimer's disease (AD), which researchers think could be effective in treating AD in its early stages. The drug, ALZ-801, is being developed by Alzheon as a potential new treatment for slowing or stopping cognitive decline in some AD patients.
Eligible participants for the study will receive either the potential new treatment drug or a placebo. The study will also help researchers gather further information about the drug’s long-term safety.
If you qualify for and decide to join the APOLLOE4 study, you may receive at no cost:
You, or the person you care for, must:
When you entrust your DNA Data and Personal Information to Sano Genetics, we commit to keeping them safe and secure. If you consent to participate, the Study Data will be stored by Sano Genetics on secure, encrypted, and wholly owned and secure servers (e.g. HIPAA compliant servers). Every part of Sano is built privacy-first and we use clear, transparent language to keep you informed at every stage throughout the process.
There are no costs to participate in this study. Genetic screening is conducted free of charge and study related travel expenses will be reimbursed.
Potential risks, disadvantages, or inconveniences are detailed below:
To enrol in this study, you will be asked to complete a pre-screening survey, upload DNA data and have your DNA data screened for the APOE4 homozygous genotype. You may find out information about your genetics you were previously unaware of. We expect that this will take no more than 20 minutes and is required to ensure you are eligible to proceed to the next steps of the study.
Participating in the study will take approximately a year and a half, and will include taking an oral treatment or placebo twice a day. Participants will also need to complete a number of visits to the study clinic, including brain scans, blood tests and tests for memory and thinking.
You will be told about any new information that might change your decision to be part of this study.
The information you provide through surveys and DNA data will be used to check if you are eligible for this study - this information will be stored securely by Sano on secure, encrypted, and wholly owned and secure servers (e.g. HIPAA compliant servers) and will not be shared with anyone else. All of your answers and DNA remain confidential. The only information we will pass on is your contact information, so that our study team can get in touch with you about the next steps, and we will only do so with your explicit permission.
Your decision to take part in this study is voluntary. You will not be penalized or lose any benefits to which you are otherwise entitled if you decide not to participate or if you decide to stop participating.
You may withdraw completely from the study at any time and withdraw the data and samples collected up until the point of withdrawal from use in any future analysis. However, any analysis or interim results that included your information prior to withdrawal cannot be undone.
You will not be paid for taking part in this research. However, if you qualify you will be reimbursed for study-related time and travel expenses.
All research is reviewed by an independent group of people, called an Institutional Review Board (IRB) or Ethics Committee (EC), to protect the rights of the people participating in the research. We will not collect any genetic information or use your information in any way before the approval of the study. Approval does not guarantee that you will not come to any harm if you take part. However, approval means that the committee is satisfied that your rights will be respected, that any risks have been reduced to a minimum and balanced against possible benefits and that you have been given sufficient information on which to make an informed decision.