Key result
Tadalafil awaits phase II results on whether it increases cerebral blood flow in small vessel disease.
Why the study?
Cerebral small vessel disease causes vascular cognitive impairment with no licensed treatment and is associated with reduced cerebral blood flow.
Does single dose oral tadalafil increase cerebral blood flow in older people with small vessel disease?
RCT (n=54)
Double-blind
Crossover
No
Does single dose oral tadalafil increase cerebral blood flow in older people with small vessel disease?
This study protocol describes a phase II trial to evaluate whether a single dose of tadalafil improves cerebral blood flow in older patients with small vessel disease.
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.
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Pauls et al. (2017) conducted an RCT in Cerebral small vessel disease (n=54). Tadalafil vs. Placebo was evaluated on Change in regional cerebral blood flow in subcortical white matter and deep grey nuclei. Tadalafil is being evaluated in a phase II randomized crossover trial to determine if a single 20 mg dose increases cerebral blood flow in older adults with small vessel disease, with results pending.
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