Professor A. Malaspina at Queen Mary University of London is leading a multi-centre study with recruitment sites within and outside London. The main goal is to establish a biological repository that covers the natural history of the disease and provides the experimental platform to test novel biomarkers to evaluate prognosis and treatment response in affected individuals.  This approach should help streamlining clinical trials, providing clinical stratification and biological outcomes of response to the medicinal product under investigation. The study has already delivered a better understanding of how the disease can be monitored and characterised using simple assays for the determination of protein levels in blood.

Any patients with ALS or with other neurological conditions, as well as healthy individuals with or without a family history of ALS, willing to take part in the study should use the following contacts:

a.malaspina@nhs.net
o.yildiz@nhs.net
Michael.andrews3@nhs.net

Tel: 0203 594 1883
Fax: 0203 594 2153

 

Study title	Characterisation of a panel of disease biomarkers in peripheral blood from individuals with amyotrophic lateral sclerosis/motor neuron disease
UK Chief Investigator	Dr Andrea Malaspina
Research summary	This study will evaluate the expression of a range of biomarkers linked to the structural and immunometabolic changes taking place in ALS in biological fluids collected from individuals with amyotrophic lateral sclerosis at different time points during the development of the disease. We will test the expression of these molecules with reference to a healthy control state and other neurological disorders. Our aim is to validate easily accessible disease biomarkers functioning as reliable predictors of disease severity and to be used for the stratification of the disease in homogeneous phenotypes. We aim also at collecting biological samples allowing cultures of specific cell types that can be used to identify novel disease biomarkers and test novel therapeutic strategies. To make the study effective, we will access clinical and diagnostic data which relate to investigation that have led to the diagnosis and related to the clinical follow-up of. Recruitment will take place in 3 motor neuron disease clinics serving a population of approximately 7,000,000 in North-East London, Heredforshire and Essex. A similar study is currently ongoing in animal models of the disease.
Inclusion/exclusion criteria	INCLUSION CRITERIA - Diagnosis of definite or probable ALS according to the El Escorial Criteria - > 16 of age EXCLUSION CRITERIA - ALS/MND patients unable to consent
Current status	Active – recruiting
Locations	Basildon London (The Royal London Hospital) London (UCL/National Hospital for Neurology and Neurosurgery)
Contact details	a.malaspina@nhs.net o.yildiz@nhs.net Michael.andrews3@nhs.net Tel: 0203 594 1883 Fax: 0203 594 2153
Recruitment group(s)	Participant groups: 1. Patients with MND 2. Neurologically healthy volunteers 3. Volunteers undergoing investigation for a suspected neurological disorder 4. Individuals with a diagnosis of a neurodegenerative, neuroinflammatory and neuromuscular disorder.
Recruitment target(s)	1200 study participants.
Key dates	Actual opening date: 24 June 2009 Recruitment planned end date: 31 December 2020
Funder(s)	Motor Neurone Disease Association (MNDA)
Sponsor	Barts and the London NHS Trust
Study design	Cohort observational
Intervention (if applicable)	Not applicable
Phase (if applicable)	Not applicable
Outcome measures
Publications / Results reports	Links will be provided when papers are published.
Participant Information Sheets	ALS Biomarkers Study - Information leaflet for index cases and their families ALS Biomarkers Study - Information leaflet for Controls