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The PASTIS trial: Testing tadalafil for possible use in vascular cognitive impairment
Author(s) -
Pauls Mathilde M.H.,
Binnie Lauren R.,
Benjamin Philip,
Betteridge Shai,
Clarke Brian,
Dhillon MohaniPreet K.,
Ghatala Rita,
Hainsworth Fearghal A.H.,
Howe Franklyn A.,
Khan Usman,
Kruuse Christina,
Madigan Jeremy B.,
Moynihan Barry,
Patel Bhavini,
Pereira Anthony C.,
Rostrup Egill,
Shtaya Anan B.Y.,
Spilling Catherine A.,
Trippier Sarah,
Williams Rebecca,
Young Robin,
Barrick Thomas R.,
Isaacs Jeremy D.,
Hainsworth Atticus H.
Publication year - 2022
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1002/alz.12559
Subject(s) - tadalafil , placebo , medicine , clinical endpoint , cerebral blood flow , blood pressure , randomized controlled trial , adverse effect , dosing , clinical trial , cardiology , vasodilation , anesthesia , erectile dysfunction , pathology , alternative medicine
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. Methods 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. Results 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. Discussion 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.