1. The PASTIS trial: Testing tadalafil for possible use in vascular cognitive impairment
- Author
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Mathilde M.H. Pauls, Lauren R. Binnie, Philip Benjamin, Shai Betteridge, Brian Clarke, Mohani‐Preet K. Dhillon, Rita Ghatala, Fearghal A.H. Hainsworth, Franklyn A. Howe, Usman Khan, Christina Kruuse, Jeremy B. Madigan, Barry Moynihan, Bhavini Patel, Anthony C. Pereira, Egill Rostrup, Anan B.Y. Shtaya, Catherine A. Spilling, Sarah Trippier, Rebecca Williams, Robin Young, Thomas R. Barrick, Jeremy D. Isaacs, and Atticus H. Hainsworth
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clinical trials ,small vessel disease ,Epidemiology ,Health Policy ,cerebral blood flow ,Psychiatry and Mental health ,Cellular and Molecular Neuroscience ,Developmental Neuroscience ,vascular cognitive impairment and dementia ,PDE5 ,Neurology (clinical) ,Geriatrics and Gerontology ,tadalafil ,vascular cognitive impairment - Abstract
Introduction\ud There are few randomized clinical trials in vascular cognitive impairment (VCI). This trial tested the hypothesis that the PDE5 inhibitor tadalafil, a widely used vasodilator, increases cerebral blood flow (CBF) in older people with symptomatic small vessel disease, the main cause of VCI.\ud \ud Methods\ud In a double-blind, placebo-controlled, cross-over trial, participants received tadalafil (20 mg) and placebo on two visits ≥7 days apart (randomized to order of treatment). The primary endpoint, change in subcortical CBF, was measured by arterial spin labelling.\ud \ud Results\ud Tadalafil increased CBF non-significantly in all subcortical areas (N = 55, age: 66.8 (8.6) years) with greatest treatment effect within white matter hyperintensities (+9.8%, P = .0960). There were incidental treatment effects on systolic and diastolic blood pressure (–7.8, –4.9 mmHg; P < .001). No serious adverse events were observed.\ud \ud Discussion\ud This trial did not identify a significant treatment effect of single-administration tadalafil on subcortical CBF. To detect treatment effects may require different dosing regimens.
- Published
- 2022
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