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Biomarkers of Alzheimer's Disease

Plasma based biomarkers for Alzheimer's Disease

Summary

This study is hoping to identify a test, sometimes called a biomarker, for Alzheimer's disease (AD). To do this various changes that may take place in the blood and urine of people with AD are measured and compared to those individuals without the illness.

Additionally, some participants are having a brain scan to investigate the changes that occur in the brain of people with AD compared to others without dementia.

Why carry out the research?

There are 500,000 people with Alzheimer’s in the UK and it is estimated that this figure will double in the next 50 years.

Despite being so common, AD remains difficult to diagnose in life, with a poorly defined clinical syndrome in the early stages.

Currently, cognitive, or memory, testing is the gold standard used to monitor the progression of the disease. However, these tests are relatively insensitive to change and highly variable. As a result of these limitations, AD clinical research including drug trials of,are of long duration and require very large numbers of study participants.

This study aims to identify and validate a set of blood based (RNA, and protein and lipid factors) and neuroimaging biomarkers for AD. It also aims to explore the changes that occur in these markers as the disease progresses.

A successful biomarker for AD would be useful in clinical practice, leading to earlier recognition and better monitoring of the disease. Also, and most importantly, it might help in clinical trial design, speeding the process of producing new treatments for this devastating and common condition.

How is the research being undertaken?

WHO ARE WE LOOKING FOR?
In the London clinical trial centre we would like to recruit a cohort consisting of 150 people with a clinical diagnosis of mild/moderate AD, 100 people with Mild Cognitive Impairment (MCI) and 90 healthy controls over the age of 65.

In the London clinical trial centre we would like to recruit a cohort consisting of 150 people with a clinical diagnosis of mild/moderate AD, 100 people with Mild Cognitive Impairment (MCI) and 90 healthy controls over the age of 65.

WHAT WILL HAPPEN IF I AGREE TO TAKE PART?
Subjects with AD will be assessed at baseline and then 3 monthly over a 12 month period. Subjects with MCI and controls will be assessed at baseline and 12 month follow-up only.

All subjects will be asked to provide biological samples (blood and urine) at each visit. Blood samples obtained by a standardised venepuncture procedure will be taken for the analysis of serum, plasma, RNA and DNA.

Researchers will also collect information from people and their carers at each visit. The data collected will assess four domains - cognition, function, behaviour and global severity.

Brain atrophy and neuronal functional changes are hallmarks of AD. Using serial MRI scanning, brain atrophy can be assessed with high reliability.

Neuroimaging, including MRI and MRS, investigations will be conducted on a sub-sample of subjects in this longitudinal study. Using these techniques the researchers will establish and validate refined neuroimaging markers for AD.

Full informed consent will be obtained from subjects wherever possible or from next of kin or primary carers.

A variety of technologies will be used to identify biomarkers in serum, plasma, RNA and DNA including biochemical assays, differential gene expression (microarray looking at RNA), proteomics and lipidomics .

Where is it happening?

This is a multi centre study and there are 5 clinical trials centres (London, Kuopio, Toulouse, Perugia and Thessaloniki).

Who is involved?

Professor Simon Lovestone in the Department of Old Age Psychiatry and Director of the NIHR Biomedical Research Centre for Mental Health is the Principal Investigator.

The study is funded by the Commission of the European communities and the NIHR Biomedical Research Centre for Mental Health at the Institute of Psychiatry and the South London and Maudsley NHS Foundation Trust.

What is the timescale?

The study started in 2006 and has been extended through the NIHR Biomedical Research Centre for Mental Health until 2012.

To find out more

Please contact:-

Professor Simon Lovestone
simon.lovestone@kcl.ac.uk

Miss Megan Pritchard
Dementia Case Register Project Lead
megan.pritchard@kcl.ac.uk

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