Abstract
BackgroundCerebral small vessel disease is a common cause of vascular cognitive impairment in older people, with no licensed treatment. Cerebral blood flow is reduced in small vessel disease. Tadalafil is a widely prescribed phosphodiesterase-5 inhibitor that increases blood flow in other vascular territories. The aim of this trial is to test the hypothesis that tadalafil increases cerebral blood flow in older people with small vessel disease.Methods/designPerfusion by Arterial Spin labelling following Single dose Tadalafil In Small vessel disease (PASTIS) is a phase II randomised double-blind crossover trial. In two visits, 7-30 days apart, participants undergo arterial spin labelling to measure cerebral blood flow and a battery of cognitive tests, pre- and post-dosing with oral tadalafil (20 mg) or placebo. Sample size: 54 participants are required to detect a 15% increase in cerebral blood flow in subcortical white matter (p < 0.05, 90% power). Primary outcomes are cerebral blood flow in subcortical white matter and deep grey nuclei. Secondary outcomes are cortical grey matter cerebral blood flow and performance on cognitive tests (reaction time, information processing speed, digit span forwards and backwards, semantic fluency).DiscussionRecruitment started on 4th September 2015 and 36 participants have completed to date (19th April 2017). No serious adverse events have occurred. All participants have been recruited from one centre, St George’s University Hospitals NHS Foundation Trust.Trial registrationEuropean Union Clinical Trials Register: EudraCT number 2015-001235-20. Registered on 13 May 2015.
Highlights
Cerebral small vessel disease is a common cause of vascular cognitive impairment in older people, with no licensed treatment
Recruitment started on 4th September 2015 and 36 participants have completed to date (19th April 2017)
As of 19 April 2017, 36 participants have completed the protocol. In this randomised, double-blind, crossover phase II study, we will test whether tadalafil (20 mg) increases cerebral blood flow (CBF) in older people with small vessel disease (SVD)
Summary
Cerebral small vessel disease is a common cause of vascular cognitive impairment in older people, with no licensed treatment. Tadalafil is a widely prescribed phosphodiesterase-5 inhibitor that increases blood flow in other vascular territories. The aim of this trial is to test the hypothesis that tadalafil increases cerebral blood flow in older people with small vessel disease. Cerebral small vessel disease (SVD) is a frequent cause of vascular cognitive impairment (VCI) in older adults [1,2,3,4]. There is evidence derived from some previous studies to suggest that cerebral blood flow (CBF) is reduced in SVD, in subcortical white matter [5,6,7,8,9,10].
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
