|Study title||Molecular Imaging of Neurodegenerative Disease – Mitochondria, Associated Proteins & Synapses – Amyotrophic Lateral Sclerosis (MIND-MAP-ALS)|
|UK Chief Investigator||Professor Ammar Al-Chalabi|
|Research summary||Amyotrophic lateral sclerosis (ALS) is the most common form of motor neurone disease. In this disease there is death of the nerve cells that control muscle movement. This leads to increasing muscle weakness, including muscles important for movement, swallowing and breathing.
The cause of this condition is still unknown, although it is thought that people’s genes and their environment play a role. Our aim is to look into the cause of this disease, so that in the future treatments can be made to slow or even stop the worsening of the condition.
We plan to use a special type of brain scan, called PET, to explore how brain activity is effected in ALS. In particular, we will measure the mitochondrial activity (the source of energy of brain cells) and synapses (the links between the nerve cells that allow communication and control of the movements). Another type of brain scan, called MRI, will be used to investigate the brain’s structure and function. Finally, we will complete a detailed clinical and psychological assessment.
We aim to follow up participants with a new ALS diagnosis (with symptoms starting in their limbs), aged between 25 and 85, over a one year period. Three clinical visits will take place at King’s College Hospital and four visits for brain scans will take place at Invicro (an imaging centre next to Hammersmith Hospital). We will reimburse transportation to and from home to the hospital and refreshments throughout the visits. We will also offer, as a small thank you, £100 per scan (up to £800).
The findings from this study will be reported at local, national and international meetings and conferences. We will maintain a high impact publishing policy, submitting to open-access, top-tier, and peer-reviewed journals and will inform participants of relevant publications.
|Inclusion/exclusion criteria||INCLUSION CRITERIA
• 25-85 years of age, male or female
• Able to give informed consent
• Adequate visual and auditory acuity to complete the psychological testing
• No presence or history of other significant neurological or psychiatric disorders
• Diagnosis of sporadic ALS according to revised El Escorial criteria63 from an experienced MND neurologist
• Limb disease onset
• Less than 6 months since ALS diagnosis
• Negative family history for ALS
• Current or a recent history of drug or alcohol abuse/dependence
• Presence of other neurological disorders and known intracranial co-morbidities such as stroke, haemorrhage, space-occupying lesions
• Pregnancy or breastfeeding
• Contraindication to MRI, such as presence of metal devises or implants, metal deposited in the body, or metal grains in the eyes
• History of cancer within the last 5 years
• Subject has received significant exposure to ionising radiation as part of research study such that with the exposure in this study they will have received > 10mSv within the previous 12 months
• Claustrophobia and history of back pain that makes prolonged laying on the PET or MRI scanner intolerable
• Contraindication to arterial cannulation, such as history of bleedings, haemorrhage etc.
• When available, positive genetic testing for familial ALS (C9orf72, TARDBP, SOD1, FUS etc)
• Presence of PEG, NIV or tracheotomy at baseline • Patients who fulfil diagnostic criteria for FTD or non-FTD dementia
• Participation to any other clinical trial involving new ALS drugs
|Current status||Active – recruiting|
|Locations||London (King’s College Hospital)|
|Contact details||Study team: firstname.lastname@example.org|
|Recruitment group(s)||Patients with MND
|Recruitment target(s)||16 patients|
|Key dates||Actual opening date: 03 October 2019
Recruitment planned end date: 30 June 2021
|Funder(s)||Invicro UK Holdings Ltd (Industry-funded, non-industry sponsored trial)|
|Sponsor||King's College London|
|Study design||Cohort observational|
|Intervention (if applicable)||Not applicable|
|Phase (if applicable)||Not applicable|
|Outcome measures||We aim compare mitochondrial and synaptic function between people with ALS and sex- and age-matched healthy volunteers (from previous database). We will also investigate for associations between mitochondrial and synaptic dysfunction and severity of symptoms.|
|Publications / Results reports||Links will be provided when papers are published.|
|Participant Information Sheet|