TY - JOUR
T1 - The PASTIS trial
T2 - Testing tadalafil for possible use in vascular cognitive impairment
AU - Pauls, Mathilde M. H.
AU - Binnie, Lauren R.
AU - Benjamin, Philip
AU - Betteridge, Shai
AU - Clarke, Brian
AU - Dhillon, Mohani-Preet K.
AU - Ghatala, Rita
AU - Hainsworth, Fearghal A. H.
AU - Howe, Franklyn A.
AU - Khan, Usman
AU - Kruuse, Christina
AU - Madigan, Jeremy B.
AU - Moynihan, Barry
AU - Patel, Bhavini
AU - Pereira, Anthony C.
AU - Rostrup, Egill
AU - Shtaya, Anan B. Y.
AU - Spilling, Catherine A.
AU - Trippier, Sarah
AU - Williams, Rebecca
AU - Young, Robin
AU - Barrick, Thomas R.
AU - Isaacs, Jeremy D.
AU - Hainsworth, Atticus H.
N1 - Publisher Copyright:
Alzheimer's & Dementia© 2022 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
KW - cerebral blood flow
KW - clinical trials
KW - PDE5
KW - small vessel disease
KW - tadalafil
KW - vascular cognitive impairment
KW - vascular cognitive impairment and dementia
U2 - 10.1002/alz.12559
DO - 10.1002/alz.12559
M3 - Journal article
C2 - 35135037
AN - SCOPUS:85124543065
VL - 18
SP - 2393
EP - 2402
JO - Alzheimer's & Dementia
JF - Alzheimer's & Dementia
SN - 1552-5260
IS - 12
ER -