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

NCT02450253 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2022-10-27

No results posted yet for this study

Summary

Could Tadalafil improve blood flow in deep brain tissue and potentially improve cognitive function in patients with cerebral small vessel disease

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

Sponsors & Collaborators

  • Alzheimer's Drug Discovery Foundation

    collaborator OTHER

  • Alzheimer's Society

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • University of Glasgow

    collaborator OTHER

  • St George's University Hospitals NHS Foundation Trust

    collaborator OTHER

  • St George's, University of London

    lead OTHER

Principal Investigators

  • Jeremy Dr Isaacs, MRCP PhD · St George's University Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-01-25
Completion
2018-01-25

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02450253 on ClinicalTrials.gov