TSPO modulation in cSVD
Research type
Research Study
Full title
Targeting 18kDa Translocator Protein (TSPO) to improve brain endothelial cell function in cerebral small vessel disease
IRAS ID
339664
Contact name
Paul Matthews
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 28 days
Research summary
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.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/LO/0540
Date of REC Opinion
11 Sep 2024
REC opinion
Further Information Favourable Opinion