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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Paul
Matthews
p.matthews@imperial.ac.uk
Daisy
Metcalf
daisy.metcalf@nhs.net
Dr
David
Owen
d.owen@imperial.ac.uk
Cerebrovascular diseases
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In healthy people, blood flow to particular areas in the brain increases when the area becomes more active. This ensures that the brain gets enough blood at the right place and time. In people with cerebral small vessel disease (cSVD), this process is disrupted, and the increased blood flow in response to activity is decreased or absent. The aim of this study is to find out whether blood flow in cSVD can be made more responsive to activity by altering the function of a protein called TSPO. We will do this by using a drug called XBD173, which binds to TSPO.
This is a double-blind, randomised, crossover study. cSVD patients will be recruited from Imperial College Healthcare Trust. Patients will undergo screening to provide consent and determine eligibility. If enrolled, the first six participants will receive XBD173 (90mg twice daily, 4 weeks) on an open-label basis, commencing 48 hours after the previous participant. Study visits 1 and 3 (days 0 and 28) include an MRI scan, blood test and baseline cognitive test (visit 1 only). Visit 2 (day 14) will involve a clinical assessment and blood test.
The Independent Data Monitoring Committee will decide after the 6th participant has finished the dosing period whether to approve the blinded crossover phase.
In the blinded crossover phase, participants will be randomised to receive XBD173 (90mg, twice daily, 4 weeks) or matched placebo to start on visit 1 and continue until visit 3. After a 6-week washout, they will be switched to receive the other intervention. They will undergo visits 4, 5 and 6 identical to visits 1, 2 and 3.
Healthy volunteers will be identified from the NIHR ICRF database or from posters displayed at ICL. They will undergo screening to provide consent and determine eligibility. If they are enrolled, they will attend the NIHR ICRF for a single MRI scan. They will not receive XBD173.
The research is funded by LifeArc.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;Imaging;
You can take part if:
You may not be able to take part if:
cSVD: - History of clinical stroke - History of frequent migraines - Known Alzheimer’s disease, lewy body disease or evidence of non-vascular neurological diseases - Conditions affecting safe engagement in the intervention. - Conditions preventing completion of study procedures, e.g. severe loss of vision or hearing - Clinically-significant renal disease (eGFR < 30 ml/min per 1.73m2) - Clinically-significant elevation of serum transaminases or known clinically significant liver disease - Contraindications to MRI scanning or exposure to gadolinium-based contrast agents - Newly commenced (within 2 months of study start) statins, antihypertensives or antiplatelet treatments - Severe respiratory disease with chronic hypoxia (sats < 92%), known CO2 retention or need for home oxygen therapy. - Use of certain medications (see full protocol for list) HV: - Contraindications to MRI scanning or exposure to gadolinium-based contrast agents - Pregnant women of childbearing potential - Clinically significant renal disease (eGFR < 30 ml/min per 1.73m2) - Severe respiratory disease with chronic hypoxia (sats < 92%), known CO2 retention or need for home oxygen therapy.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Daisy
Metcalf
daisy.metcalf@nhs.net
Dr
David
Owen
d.owen@imperial.ac.uk
Prof
Paul
Matthews
p.matthews@imperial.ac.uk
The study is sponsored by Imperial College of Science, Technology and Medicine and funded by Medical Research Council (MRC) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 62591
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