Perfusion by Arterial Spin Labelling Following Single Dose Tadalafil in Small Vessel Disease (PASTIS) Trial

PHASE2CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

January 25, 2018

Study Completion Date

January 25, 2018

Conditions
Dementia, Vascular
Interventions
DRUG

Tadalafil

single dose, 20 mg capsule p.o.

DRUG

Placebo

single dose, matching capsule p.o.

BEHAVIORAL

Cognitive functioning tests

Cognitive function tests will be performed prior to MRI scan 1 performed prior to IMP dosing on 2 occasions as patient will act as their own control

BEHAVIORAL

Neuropsychological tests

"Neuropsychological tests will be performed prior to pre IMP dose MRI scan \& then parallel V2 of the tests repeated 3-5 post IMP dose and before 2nd MRI scan.~Participants act as own controls as 1 IMP occasion will be placebo- 2nd IMP occasion will be active. 7-30 days apart"

OTHER

MRI Scan - Arterial Spin Labelling

Pre and post IMP dose on 2 occasions to detect difference in blood flow in deep brain 4 MRI scans in total

Trial Locations (1)

SW17 0QT

St George's Healthcare NHS Trust, London

All Listed Sponsors
collaborator

Alzheimer's Drug Discovery Foundation

OTHER

collaborator

Alzheimer's Society

OTHER

collaborator

University of Copenhagen

OTHER

collaborator

University of Glasgow

OTHER

collaborator

St George's University Hospitals NHS Foundation Trust

OTHER

lead

St George's, University of London

OTHER

NCT02450253 - Perfusion by Arterial Spin Labelling Following Single Dose Tadalafil in Small Vessel Disease (PASTIS) Trial | Biotech Hunter | Biotech Hunter