Alzheimer’s disease (AD) is the most common cause of dementia and it affects an estimated 26.6 million worldwide. It is a physical disease affecting the brain. During the course of the disease, protein ‘plaques’ and ‘tangles’ develop in the structure of the brain, leading to the death of brain cells which lead to symptoms which can include loss of memory, mood changes, and problems with communication and reasoning. Current approved medical therapies may temporarily improve the symptoms of AD in some patients, but do not modify progression of the disease.

CREAD is a clinical research study, sponsored by Roche, which is looking at the effect of a developmental drug, which works to target the ‘plaques’ and other proteins involved in AD.  Around 750 participants will take part in the study in the UK and worldwide.

What are the main aims of the study?

CREAD is a clinical research study aimed at people aged 50 to 85 with early Alzheimer’s or memory or thinking problems that may be early symptoms of Alzheimer’s disease
The main aim of study is to find out the effects, good or bad, of a new study drug when compared to a dummy drug (inactive) on participants with early Alzheimer’s disease (AD) and their memory problems. In this study, you will be randomly assigned to receive either active or dummy drug in addition to any treatment you may be receiving.

 

Chief investigator, Dr Iracema Leroi, Consultant Psychiatrist, Manchester Mental Health and Social Care NHS Trust

Chief investigator, Dr Iracema Leroi, Consultant Psychiatrist, Manchester Mental Health and Social Care NHS Trust

What does it involve for a participant?

The study will last for 3 years, which includes a screening period of up to 8 weeks, a 2-year dosing period and 1 year of follow-up.

If you decide you are interested in joining the trial, you would first be assessed for eligibility in the screening period, to make sure the study is right for you. During the 2-year dosing period you would receive either the investigational study drug or a dummy medication that does not contain any active ingredients every 4 weeks. Finally, during the follow-up period, you would be monitored but would not receive the investigational drug or placebo. Throughout all study periods, your general health and symptoms would be monitored. All study-related medications and procedures would be at no cost, and travel costs will be reimbursed.

To participate in the study, you would need a friend or relative who sees you frequently enough to be able to provide accurate information about how you are managing with your thinking and daily living skills. They would also need to attend clinic visits with you when necessary and be available to answer questions about your symptoms and any changes they notice.

How long is the study for?

The study will last for 3 years, which includes a screening period of up to 8 weeks, a 2-year dosing period and 1 year of follow-up. The majority of the visits will occur within the first 2 years. At the end of this study, you may be eligible to participate in an extension to this study where you will receive active drug. There are 30 study visits during the 3 years. You can claim expenses for travel to the hospital, and light refreshments at reasonable costs during your study visits and scans, but you will not be paid for taking part in the study.

What do you hope the outcomes of the study will be?

It is hoped that this study will show that the drug is a well tolerated and effective treatment for early AD.

Where is the study based?

There are currently 9 UK sites taking part in this study:

1. Coventry And Warwickshire Partnership NHS Trust
2. Lancashire Care NHS Foundation Trust
3. Oxford University Hospitals NHS Trust
4. Imperial College Healthcare NHS Trust
5. South Devon Healthcare NHS Foundation Trust
6. Manchester Mental Health NHS Social Care Trust
7. St George’s Healthcare NHS Trust
8. The Newcastle Upon Tyne Hospitals NHS Foundation Trust
9. Surrey And Borders Partnership NHS Foundation Trust