The AMARANTH Study is a clinical research study for men and women who may have early Alzheimer’s disease. It is being conducted worldwide to find out if the investigational drug is safe and effective in slowing down the progression of the disease.
- Approximately 2200 participants are expected to join this study worldwide.
- To join the study, you will need a study partner. This should be a caregiver, friend, or relative who:
- Is in regular contact with you
- Can attend all study visits with you, and
- Will be able to comment on changes in your health, ability to perform certain activities, and mental functioning
- All investigational study medication and study procedures / medical tests will be provided at no charge.
- It is voluntary to join the study and you can quit at any time and for any reason with no penalty.
- Not everyone who wants to join the study will qualify.
What is Alzheimer’s Disease?
- Alzheimer’s disease is a type of dementia – which means memory loss and difficulties thinking, problem-solving and communicating.
- Dementia develops due to changes in the structure and composition of the brain.
- These changes affect the brain’s ability to function properly when performing certain ‘mental’ activities. This is known as cognitive impairment.
- Over time, the brain becomes increasingly damaged, which is why the dementia gets worse.
- Alzheimer’s disease is very common and is more likely the older you are. It affects:1
- 1 in 1,400 people aged 40-64 years
- 1 in 100 people aged 65-69 years
- 1 in 25 of people in their 70s
- 1 in 6 people aged 80 years or over.
Reference: 1. www.alzheimers.org.uk
What is the investigational study drug?
- In Alzheimer’s disease, plaques and tangles of protein accumulate in the brain.
- They cause damage in your brain, so over time your brain doesn’t work as well, which means you have difficulty in thinking, learning, and remembering things.
- The plaques are made out of sticky protein called amyloid.
- The study drug is designed to reduce the creation of substances that will eventually become amyloid, and it may therefore slow down the deterioration of the brain in people with early Alzheimer’s disease. This study will test if this actually occurs.
What will happen next?
If you are interested in the AMARANTH Study take the pre-qualification screener. If you pre-qualify for the study you will be referred to a study center near you. If the study doctor determines you are eligible to participate, you will be randomly assigned (like flipping a coin) to one of the following study treatment groups:
- Group 1: lower-dose investigational study drug
- Group 2: higher-dose investigational study drug
- Group 3: placebo (which is a tablet that has no active drug in it).
You will have a 2 in 3 chance of receiving the investigational study drug.
This is a double-blind study which means neither you, your study partner, nor your physician will know to which of these study groups you are assigned. This is done to make sure the results of the study cannot be unfairly influenced by anyone. In case of urgent need, your study doctor or the study team will be able to quickly find out what group you are in.
All study drug will be in the form of a tablet, to be taken in the morning, every day of the study treatment period, unless the study team asks you to take it at another time.
How long will the study treatment last?
If you join the AMARANTH Study, your overall participation in the study will last approximately two years.
The study is divided into 3 parts:
- Screening period: To assess whether you are eligible to take part in the study. This takes place over a period of about 8 weeks.
- Treatment period: During this 2 year period you will take your study medication each day and attend regular study visits with your study partner.
- Follow-up period: You will come back to the study clinic for a follow-up visit around 4-6 weeks after you finish your study treatment. This will be your final contact with the study team.
There are 21 scheduled visits during the study; 17 will take place at the clinic and 4 will be conducted by telephone with you and/or your study partner.
What about side effects?
As with all medications, there is a possibility that you may experience side effects. The study site staff (doctor or study nurse) will talk you through all known side effects and risks before you decide if you want to participate. The study doctor and team will monitor your health throughout your participation in the study and discuss any concerns you may have.
If you do experience side effects and/or discomfort during the study, you can contact the study doctor at any time to discuss the best course of treatment, which may include discontinuation of the investigational study medication.
How do I take part?
If you would like to take part in the AMARANTH Study, take the pre-qualification screener.
If you pre-qualify for the AMARANTH Study you will be referred to a study center near you. The staff at the study center will discuss the AMARANTH Study with you in more detail. The study doctor at the study center will ask you some medical questions to see if you are able to participate in this clinical research study.