Does Tadalafil improve deep brain blood flow which could lead to improved cognitive functio

Phase 1

• Conditions: PARTICIPANTS WITH EVIDENCE OF CEREBRAL SMALL VESSEL DISEASE; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-001235-20-GB
• Lead Sponsor: St George's University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-13
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 90

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 < 24 hours with limb weakness, hemi-sensory loss or dysarthria at least 6 months previously AND with MRI DWI performed acutely showing lacunar infarction, OR if MRI is not performed within 10 days of TIA, a lacunar infarction in an anatomically appropriate position is demonstrated on a subsequent MRI

3. Age = 55 years.

4. Imaging of the carotid arteries with Doppler ultrasound, CT
angiography or MR angiography in the previous 12 months,
demonstrating < 70% stenosis in both internal carotid arteries
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

1. Known diagnosis of dementia
2. Cortical infarction (>1.5 cm maximum diameter)
3. Systolic BP <90 and/or diastolic BP < 50
4. Creatinine Clearance<50ml/min
5. Severe hepatic impairment
6. History of Lactose intolerance
7. Concomitant use of PDE5 inhibitors e.g. sildenafil, tadalafil, vardenafil.
8. Concomitant use of alpha-blockers e.g. alfuzosin, doxazosin, indoramin, prazosin, tamsulosin, and terazosin can all increase the risk of postural hypotension.
9.Participants receiving nicorandil and nitrates e.g. isosorbide mononitrate, isosorbide dinitrate, glyceryl trinitrate
10. weight > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified