Actively Recruiting
Targeting 18kDa Translocator Protein (TSPO) to Improve Brain Endothelial Cell Function in Cerebral Small Vessel Disease
Led by Imperial College London · Updated on 2024-10-15
106
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. Damage to the endothelial cells, that form the inner lining of blood vessels, is a key pathological process in cSVD. The aim of this study is to find out whether endothelial cell function and blood flow in cSVD can be improved 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 memory clinics at Imperial College Healthcare NHS Trust. Participants will be invited to the clinical research facility (CRF) at Hammersmith Hospital and randomised to receive XBD173 or matched placebo, twice daily, for 4 weeks. After a 6-week washout, they will be switched to receive the other intervention. The study visits will involve MRI scans and blood tests to assess endothelial cell function. Healthy volunteers will also be recruited for image optimisation and control data. They will attend for a single MRI scan and not receive XBD173.
CONDITIONS
Official Title
Targeting 18kDa Translocator Protein (TSPO) to Improve Brain Endothelial Cell Function in Cerebral Small Vessel Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 60 to 90 years inclusive
- Male or postmenopausal female
- Men willing to use contraception during treatment and for 90 days after last dose
- Able to provide written informed consent before any study procedures
- Have AA genotype at rs6971 (TSPO) locus
- Imaging diagnosis of cerebral small vessel disease with Fazekas score of at least 2 in periventricular and deep white matter
- Have mild cognitive impairment with MoCA score between 18 and 30
- Willing to be genotyped at TSPO and ApoE loci
- Healthy volunteers aged 60 to 90 years inclusive, male or female
- Healthy volunteers able to provide written informed consent before any study procedures
- Healthy volunteers willing to be genotyped at TSPO and ApoE loci
You will not qualify if you...
- History of clinical stroke
- History of frequent migraines
- Known Alzheimer's disease, Lewy body disease, or non-vascular neurological diseases
- Conditions preventing safe participation or completion of study procedures, such as severe vision or hearing loss
- Clinically significant renal disease (eGFR less than 30 ml/min per 1.73m2)
- Clinically significant elevation of liver enzymes or known significant liver disease
- Contraindications to MRI or gadolinium-based contrast agents
- Newly started (within 2 months) statins, antihypertensives, or antiplatelet treatments
- Severe respiratory disease with chronic hypoxia (oxygen saturation less than 92%), known CO2 retention, or need for home oxygen therapy
- Use of severe or moderate P450 CY3A4 inhibitors or inducers, including listed medications
- Use of oral contraceptives
- Use of levothyroxine
- Pregnant women of childbearing potential (for healthy volunteers)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Imperial Clinical Research Facility
London, United Kingdom
Actively Recruiting
Research Team
D
David Owen, PhD
CONTACT
D
Daisy Metcalf
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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