Improving brain blood flow in patients with cerebral small vessel disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to enhance endothelial cell function and blood flow in patients with cerebral small vessel disease (cSVD) by targeting a protein called TSPO using a drug named XBD173. It is a double-blind, randomized, crossover study where participants will receive either the drug or a placebo twice daily for four weeks. Patients will be recruited from memory clinics at Imperial College Healthcare NHS Trust and will undergo genotyping to assess their eligibility. The study will evaluate the effects of the intervention on blood flow response in the brain during activity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Aged 60-90 years inclusive Male or postmenopausal female

\- Men are eligible to participate if they are willing to use the contraception methods listed in the PIS, during treatment and for 90 days after the last dose of treatment Able to provide written informed consent prior to any study-mandated procedures AA genotype at rs6971 (TSPO) locus Imaging-based diagnosis of cSVD (Fazekas score of at least 2 for periventricular and 2 for deep white matter) Mild cognitive impairment (MoCA 18-30) Willing to be genotyped at TSPO and ApoE loci

Inclusion Criteria (Healthy Volunteers):

Aged 60-90 years inclusive Male or female Able to provide written informed consent prior to any study-mandated procedures.

Willing to be genotyped at TSPO and ApoE loci

Exclusion Criteria:

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 the following medications or therapies:

* Severe and moderate P450 CY3A4 inhibitors: Boceprevir, Clarithromycin, Cobicistat, Idelalisib, Itraconazole, Ketoconazole, Nelfinavir, Ritonavir, Saquinavir, Telaprevir, Telithromycin, Voriconazole, Aprepitant, Conivaptan, Crizotinib, Diltiazem, Dronedarone, Erythromycin, Fluconazole, Imatinib, Isavuconazole, Nefazodone, Netupitant, Nilotinib, Posaconazole, Tofisopam, Verapamil, Delavirdine.
* Severe and moderate P450 CY3A4 inducers: Carbamazepine, Enzalutamide, Fosphenytoin, Mitotane, Phenytoin, Rifampicin, Bosentan, Efavirenz, St John's wort, Barbiturates, Nevirapine, Primidone, Rifabutin, Rifapentine.
* Oral contraceptives
* Levothyroxine

Exclusion Criteria (Healthy Volunteers):

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.

Where it's running

• Imperial Clinical Research Facility
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: David Owen, PhD
• Email: d.owen@imperial.ac.uk
• Phone: +442033136195

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cerebral Small Vessel Disease Progression by Stroke Type

  This study tests whether CSVD progresses differently if a patient has a concurrent ischemic stroke, using MRI and blood biomarkers in adults.

  Recruiting University Hospital Ulm · Ulm, Baden-Wurttemberg · NCT07611136

• Brain activity and thinking problems in cerebral small vessel disease

  This project will see if EEG brain signals and home-based cognitive training or tACS can detect and improve thinking problems in older adults with cerebral small vessel disease.

  Recruiting University Hospital, Bordeaux · Bordeaux · NCT07068620

• PUFFINS Brain Health Imaging

  This project will try lower-cost low-field, ultra-low-field, and field-cycling MRI scans alongside standard 3T MRI to image the brains of adults aged 50+ with cerebral small vessel disease who do not report memory problems.

  Recruiting at 2 sites University of Aberdeen · Aberdeen and 1 other locations · NCT06947876

• Edaravone Dexborneol sublingual tablets for acute small-vessel ischemic stroke

  This trial will test whether taking Edaravone Dexborneol sublingual tablets twice daily helps adults aged 30–80 who recently had a small subcortical ischemic stroke.

  Recruiting Phase 3 Peking Union Medical College Hospital · Beijing · NCT06674460

• Exploring the link between deep medullary veins and cognitive issues in small vessel disease

  This study is trying to see if changes in certain brain veins are linked to thinking problems in people with small vessel disease.

  Recruiting Zigong No.1 Peoples Hospital · Zigong, Sichuan · NCT05715710

• Using GLP-1 analogue to prevent progression of small vessel disease

  This study is testing if a new medication can help people with moderate-to-severe small vessel disease in the brain slow down its progression compared to standard treatment alone.

  Recruiting at 2 sites Phase 2 Chinese University of Hong Kong · Wenzhou, Zhejiang and 1 other locations · NCT05356104

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.