Extract

Background and study aims Alzheimer’s disease (a mental disorder) is a major public health issue and there is a clear need to discover and develop treatments that can stop or at least delay disease progression. Unfortunately, although we have drug treatments that can reasonably improve some of the symptoms of Alzheimer's disease, we do not yet have treatments that can slow down or stop deterioration. Minocycline is an antibiotic drug that has also been shown to slow down deterioration in some research using animal models. This makes it the most promising drug for treatment that is not currently in trials and it is cheap and well tolerated. This study will find out the effects of two years of minocycline treatment on deterioration in mental processes and activities of daily living in patients with early Alzheimer's disease assessed and managed within NHS Memory Services. If minocycline can be shown to be working well, this would rapidly pave the way for further studies and ultimately the availability of a low cost and safe treatment for this common and devastating condition. Who can participate? Any patient aged 50 or over, diagnosed with Alzheimer's disease, can participate in this study. What does the study involve? Participants will be randomly allocated to one of three groups: daily treatment with 400 mg minocycline, 200 mg minocycline or a dummy drug (placebo). They will undergo this treatment for two years. What are the possible benefits and risks of participating? It is possible that minocycline may slow the rate of progression of disease or reduce symptoms of Alzheimer’s disease, but this cannot be guaranteed. Participation will provide useful information about the disease and minocycline. It is possible that patients may experience side effects from taking the study drug. These side effects may include nausea, diarrhoea and dizziness. Rarely the drug can cause increased sensitivity to sunlight and, very rarely, joint pain. In addition, there is always a risk of unknown side effects occurring. Where is the study run from? The study is run across 20 sites in England and Scotland. When is study starting and how long is it expected to run for? The study started in June 2013 and will run until 2018. Who is funding the study? The study is funded by the National Institute of Health Research (NIHR), UK. Who is the main contact? Dr Olga Zubko [email protected]

Inclusion criteria

• Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Dementia; Disease: Alzheimer's Disease

Links

• ictrp
• isrctn