ALS biomarkers study

Characterisation of a panel of disease biomarkers in peripheral blood from individuals with amyotrophic lateral sclerosis/motor neuron disease

Professor Andrea Malaspina is leading a multicentre 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.

ALS biomarkers study home collection kits

Who can take part?

Any patients with ALS or with other neurological conditions, as well as healthy individuals with or without a family history of ALS, can take part in the study. All study activities can be completed entirely remotely (consent, questionnaires, providing biosamples using simple at-home collection kits), meaning that no visits to the study site are required.

To find out more about the study, contact the study team:

Professor Andrea Malaspina, Principal Investigator:

Iman Khwaja, Research Assistant:

Luca Zampedri, Clinical Research Nurse:

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 amyotrophic lateral sclerosis (ALS) in biological fluids collected from individuals with ALS 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 also aim 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 investigations that have led to the diagnosis and the clinical follow-up. Recruitment will take place in three motor neuron disease (MND) clinics serving a population of approximately 7,000,000 in North-East London, Herefordshire and Essex. A similar study is currently ongoing in animal models of the disease.

Current status

Active – recruiting

Key dates

Actual opening date: 24 June 2009

Recruitment planned end date: 31 December 2025

Recruitment groups

Recruitment targets

Between 1,500 and 2,700 participants in total, broken down into the recruitment groups:

Click here to see how many participants have been recruited into this study to date (external link to the NIHR public study search)


Information about study sites

Contact details

Email:, and

Inclusion / exclusion criteria

Inclusion criteria

*Please note that this study also recruits patients without neurological disorders (healthy controls) and patients with non-ALS/MND neurological disorders (neurological controls).

Exclusion criteria


Barts and the London NHS Trust

Study design

Cohort observational

Outcome measures

Participant information sheets

Participant information for patients (PDF, 170KB)

Participant information for controls (PDF, 172KB)