Extrait

Background and study aims Alzheimer’s disease (AD) is the most common cause of dementia, creating problems with memory, thinking and behaviour (cognitive function). It is a growing problem worldwide, affecting millions of people over the age of 60. Current treatments focus on improving symptoms, such as memory loss, however very few treatments are able to slow stop or stop the disease from progressing (getting worse). The exact cause of AD is unknown, however many scientists believe that it is related to the protein tau. This protein is important for making sure the nerve cells in our brains function properly. In AD, this protein causes important fibres within the nerve cells to ‘tangle’, gradually destroying them. ACI-35 is a vaccine which has been designed to produce antibodies against the tangled tau proteins, to prevent their build-up and potentially prevent progression of the disease. The aim of this study is to test the safety of this vaccine and the level of antibodies it produces in the body when it is given in different doses. Who can participate? Adults aged between 60 and 85 with mild to moderate Alzheimer’s disease. What does the study involve? Participants are randomly allocated into groups who receive either a low, medium or high dose of ACI-35 or a placebo (inactive medication). This medication is given as an injection 2, 3 or 5 times over a 6 month period. Participants are also given a booster injection after 6 or 16 months. Participants in all groups are regularly assessed at clinic visits in order to test the levels of antibodies in their blood. What are the possible benefits and risks of participating? A potential benefit is that the vaccine may help to slow the progression of Alzheimer’s disease. Risks of participating include possible side-effects of the medication. Where is the study run from? One hospital in Turku (Finland) and hospitals in Bath, Liverpool, Edinburgh and London (UK). When is the study starting and how long is it expected to run for? July 2013 to June 2017 Who is funding the study? 1. AC Immune SA (Switzerland) 2. Janssen Pharmaceuticals, Inc. (UK) Who is the main contact? 1. Ms Eva Schier (Public) 2. Mr Julian Gray (Scientific)

Critère d'inclusion

• Alzheimer's disease

Liens

• ictrp
• isrctn