The PASTIS Trial: Testing Tadalafil for Possible Use in Vascular Cognitive Impairment

Overview

Journal Alzheimers Dement

Specialties Neurology
Psychiatry

Date 2022 Feb 8

PMID 35135037

Authors

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

Atticus H Hainsworth

Affiliations

Soon will be listed here.

Abstract

Introduction: 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.

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