Take part in our trial of tadalafil

Below is some more information about taking part in a trial that we are funding with the Alzheimer's Drug Discovery Foundation, looking at whether an existing drug called tadalafil may help to treat a common cause of vascular dementia. 

What is the study testing?

This clinical trial is called PASTIS. The aim of the PASTIS study is to ask whether a drug called tadalafil can increase blood flow in the brain. Insufficient blood flow to the brain can lead to damage to the cells, and is a common cause of vascular dementia. Tadalafil may help to increase blood flow to the brain and delay or prevent this cell damage.

Tadalafil is already licensed to treat erectile dysfunction. We know that it is safe to use in people and we know the possible side effects. 

Who can take part? 

The researchers are looking for men and women over the age of 50 who have had a small stroke or transient ischaemic attack as seen on a magnetic resonance imaging (MRI) brain scan more than six months ago, but do not have a diagnosis of dementia.

Where is the study happening?

The study is taking place at St George's University Hospital in South West London.  

What does the study involve? 

You will first need to go for an initial meeting at the hospital to make sure that you are eligible for the study and for the study team to answer any questions you may have. This will take about an hour and will involve a few tests (including taking your blood pressure) and questionnaires.

People who are eligible for the trial and wish to take part will then be scheduled to visit the hospital two more times. Each participant will take tadalafil on one visit and a placebo (dummy drug) on another visit. The order in which you receive the drug is random, so you may receive the placebo on the first visit then tadalfil on the second visit or vice versa. Neither you nor the people administering the study medication know which one is which in order to ensure the study is 'blinded' (an important part of clinical trials). These visits will also involve having brain scans using a method called magnetic resonance imaging (MRI), and some brief cognitive tests.

What will happen after the study?

This type of study is known as a Phase II clinical trial. The researchers are making sure that the drug works in the way they are expecting (by improving blood flow to the brain). 

If this study does show these outcomes, we hope to be able to run a larger, longer trial to find out whether taking the drug can reduce risk of developing vascular dementia in the future. 

I believe I am eligible and would like to take part, what do I do now? 

Please call the Stroke Research Office at St George’s Hospital on 020 8725 4474 and quote 'PASTIS', or email Dr Mathilde Pauls on mpauls@sgul.ac.uk. The research team will go through more details of the study with you and answer any initial questions you may have.