Extrait

Background and study aims Dementia is increasingly common in the aging population, affecting around 35.6 million people worldwide. People with dementia have difficulties with mental processes such as memory, language, reasoning and identifying people and objects, which become progressively worst over time. Vascular dementia (VaD) is the second most common type of dementia (after Alzheimer's disease), and is caused by a reduced flow of blood to the brain because of diseased blood vessels. There are several types of VaD, the most common being subcortical ischemic vascular dementia (SIVD). SVID happens when the tiny blood vessels deep in the brain become blocked due to the build-up of a fatty substance called plaque on the vessel walls. Currently there are no approved treatments or on-going studies looking at the treatment of SIVD. There is a potential opportunity to improve treatment for people with SIVD by lowering their blood pressure to a slightly lower level than is usually achieved with standard treatment. This approach has been successful in reducing the risk of memory problems in people who have had a stroke, and may also have benefits for people with SIVD. The aim of this study is to find out whether a more rigorous approach to reducing blood pressure can effectively reduce blood pressure in people with SIVD and will begin to look at whether there are other benefits in terms of memory and changes on a brain scan. Who can participate? Adults aged 50 and over who have SIVD are live in Wales. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group receive intensive treatment to lower their blood pressure, with a target of less than 125mmHg systolic pressure (the highest pressure when the heart beats and pushes the blood round the body). This is done using a formula that takes into account the current guidelines for treating people with stroke, high blood pressure and type 2 diabetes, and prioritizing use of the drug amlodipine (a drug which relaxes blood vessels to improve blood flow) where appropriate. Those in the second group receive blood pressure management which reflects the current guidelines, aiming for a less than 140mmHg systolic pressure. Participants in both groups complete a number of questionnaires at the start of the study and then after 13, 26 and 52 weeks in order to test their cognitive function (thinking, memory and understanding), executive function (mental skills that help a person to get things done) and quality of life. Participants also have an MRI (brain scan) at the start of the study and at 52 weeks in order to find out if the damage to their brain caused by the SIVD has gotten worse. What are the possible benefits and risks of participating? Participants may benefit from an improvement of their SIVD symptoms as a result of better controlling their blood pressure. There is a small risk that the drugs used in this study might react with other medications a patient is taking, including over the counter medications and herbal products. Participants medications are therefore monitored closely to avoid this. Participants in this study are also advised not to consume grapefruit, as it can interact with some medications. Where is the study run from? King's College London (UK) When is the study starting and how long is it expected to run for? February 2016 to August 2018 Who is funding the study? The Waterloo Foundation (UK) Who is the main contact? 1. Professor Clive Ballard (scientific) 2. Miss Olga Borejko (public)

Critère d'inclusion

• Subcortical ischaemic vascular dementia

Liens

• isrctn
• ictrp