PARTICIPANTS WITH EVIDENCE OF CEREBRAL SMALL VESSEL DISEASE
Conditions
Interventions
Trade Name: CIALIS
Product Name: Tadalafil
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: TADALAFIL
CAS Number: 171596-29-5
Sponsors
St George's University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Radiological evidence of cerebral small vessel disease defined as: MRI evidence of lacunar infarct(s) (= 1.5 cm maximum diameter) and/or confluent deep white matter leukoaraiosis (= grade 2 on Fazekas scale) 2. Clinical evidence of cerebral small vessel disease can be: a) lacunar stroke syndrome with symptoms lasting >24 hours, occurring at least 6 months previously; OR: b) transient ischaemic attack lasting =65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Known diagnosis of dementia 2. Cortical infarction (>1.5 cm maximum diameter) 3. Systolic BP 130kg 11 Uncontrolled cardiac failure 12. Persistent or paroxysmal atrial fibrillation 13. History of gastric ulceration 14. History of ‘sick sinus syndrome’ or other supraventricular cardiac conduction conditions such as sinoatrial or atrioventricular block 15. Uncontrolled COPD 16. Stroke or TIA within the last 6 months 17. MRI not tolerated or contra-indicated : MRI exclusion criteria -Participant has a cardiac pacemaker; recent surgery; vascular clips; metal implants or joint replacements; have had metal fragments in their eyes; has ever worked on a lathe; has shrapnel from a war injury; possibility of pregnancy 18. Known monogenic causes of stroke e.g.. CADASIL 19 Unable to provide informed consent 20. enrolled in another CTIMP study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does Tadalafil increase blood flow in deep brain tissue?; Secondary Objective: Does Tadalafil increase blood flow in cerebral cortex grey matter? Does Tadalafil increase cognitive speed and attention? Does plasma tadalafil concentration correlate with changes in brain blood flow? ;Primary end point(s): change in local cerebral blood flow within deep brain nuclei and deep white matter;Timepoint(s) of evaluation of this end point: Shortly before and 3-5 hours following stat dosing at 2 individual time points (patients are their own controls). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in regional CBF in cortical grey matter areas. serum [drug concentration] dependence of deep CBF. Changes in neuropsychological parameters including attention and cognitive speed. ;Timepoint(s) of evaluation of this end point: Shortly before and 3-5 hours following stat dosing at 2 individual time points (patients are their own controls). | — |
Countries
United Kingdom
Outcome results
None listed