Perfusion by Arterial Spin Labelling following Single dose Tadalafil in Small vessel disease (PASTIS): study protocol for a randomized controlled trial

Pauls, M. et al. (2017) Perfusion by Arterial Spin Labelling following Single dose Tadalafil in Small vessel disease (PASTIS): study protocol for a randomized controlled trial. Trials, 18, 229. (doi: 10.1186/s13063-017-1973-9) (PMID:28532471) (PMCID:PMC5440904)

Abstract

Background: Cerebral 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/design: Perfusion 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). Discussion: Recruitment 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 registration: European Union Clinical Trials Register: EudraCT number 2015-001235-20. Registered on 13 May 2015.

• Item Type: Articles
• Additional Information: The study is jointly funded by the Alzheimer’s Drug Discovery Foundation and the Alzheimer’s Society (grant reference 20140901). NC is funded by MRC doctoral training programme grant number MR/N013638/1.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Haig, Dr Caroline
• Authors: Pauls, M., Clarke, N., Trippier, S., Betteridge, S., Howe, F., Khan, U., Kruuse, C., Madigan, J., Moynihan, B., Pereira, A., Rolfe, D., Rostrup, E., Haig, C., Barrick, T., Isaacs, J. D., and Hainsworth, A. H.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre
• Journal Name: Trials
• Publisher: BioMed Central
• ISSN: 1745-6215
• ISSN (Online): 1745-6215
• Copyright Holders: Copyright © 2017 The Authors
• First Published: First published in Trials 18: 229
• Publisher Policy: Reproduced under a Creative Commons License