CompletedNot ApplicableInterventional

Understanding how increasing some of the brain's chemicals can help thinking and behaviour in people with Parkinson’s disease

Parkinson’s disease affects natural brain chemicals that help control both movement and thinking. While common treatments focus on boosting dopamine, another important brain chemical called noradrenaline also declines. This trial tests whether boosting noradrenaline with a medicine called atomoxetine can help sharpen concentration, memory, and decision-making. Taking part involves two visits to Addenbrooke’s Hospital in Cambridge, spaced a few weeks apart. At one visit, you will receive a single tablet of atomoxetine, and at the other, an inactive dummy pill (placebo). Neither you nor the researchers will know which tablet you receive first. Each visit lasts up to five hours. You will have routine health checks, relax in a quiet room, give a small blood sample, and complete simple computerised puzzles to measure your thinking skills. Although this trial will not cure Parkinson’s, your time could help scientists discover better treatments for thinking problems in the future.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrolment target

Start

29 Mar 2018

Estimated completion

29 Mar 2019

Parkinson's disease

What is this study about?

Our brains rely on chemical messengers called neurotransmitters to pass signals between cells. In Parkinson’s disease, several of these messengers drop below normal levels. Most current treatments replace dopamine, which is vital for easing movement problems like stiffness and tremor. However, Parkinson’s also lowers noradrenaline, another essential chemical that helps with alertness, focus, and quick decision-making.

This study explores whether a medicine called atomoxetine can help support these mental processes. Atomoxetine is already safely prescribed in the UK for conditions like Attention Deficit Hyperactivity Disorder (ADHD) because it increases noradrenaline levels in the brain. Researchers want to see if taking a single standard dose can temporarily boost attention and thinking skills in people living with mild to moderate Parkinson’s.

Taking part helps researchers better understand how brain chemicals interact with thought processes in Parkinson's. While this trial will not change your long-term condition, the information gathered could pave the way for new and improved treatments designed to help people manage thinking and memory changes in everyday life.

Key takeaways

Tests whether boosting the brain chemical noradrenaline helps thinking skills in Parkinson's disease.
Requires two study visits to Addenbrooke’s Hospital in Cambridge, lasting up to five hours each.
Compares a single 40mg dose of atomoxetine with a dummy pill (placebo).
Involves simple memory and attention computer tasks, blood pressure checks, and a small blood sample.
Travel expenses for you and a companion are reimbursed.
You cannot drive home after the visits and will need to arrange transport.

Who may be eligible?

This trial is designed for people aged between 45 and 80 who have been diagnosed with Parkinson’s disease at a mild to moderate stage. You must be able to speak English and have normal or corrected vision (with glasses) so you can clearly see the computer screen during the thinking tasks.

To ensure your safety, you cannot join if you have certain existing health conditions. These include dementia or significant memory problems, severe depression, heart disease, irregular heart rhythms, or high blood pressure that is not under control. You will also be excluded if you have severe kidney or liver problems, epilepsy, or if you take blood-thinning medicines such as warfarin.

In addition, because some study procedures involve sensitive scanning equipment, people with certain metal implants (such as pacemakers or some surgical joint replacements) cannot take part. The research team will review your full medical history and current prescriptions to make sure joining the trial is safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have been diagnosed with Parkinson’s disease (mild to moderate stage).
I am between 45 and 80 years old.
I can speak English and have normal vision (or vision corrected with glasses).
I do not have heart disease, uncontrolled blood pressure, or a pacemaker.
I do not have dementia, severe depression, or a history of epilepsy.
I am not currently taking warfarin or monoamine oxidase inhibitors (MAOIs).

Answer every question to see your result.

What does participation involve?

Taking part involves two separate visits to Addenbrooke’s Hospital in Cambridge, usually spaced about two weeks apart (and up to eight weeks apart at most). Each session lasts up to five hours and includes plenty of rest breaks.

During each visit, the medical team will check your blood pressure and may run a simple heart tracing test (ECG). You will then swallow a tablet with water. At one visit, the pill will contain a standard 40mg dose of atomoxetine; at the other visit, it will be a dummy pill (placebo). You will rest in a comfortable lounge with a TV and magazines for around two hours while the medicine is absorbed.

Next, the team will take a small blood sample (about two teaspoons) to check medicine levels. You will then spend up to two hours completing simple computerised tests and puzzles that assess your memory, concentration, and reaction times. You do not need any computer experience to do these. Because the medicine can cause mild sleepiness or dizziness, you must arrange for someone to take you home, as you cannot drive or operate machinery for the rest of the day.

Potential risks and benefits

There is no direct medical benefit to taking part, but you will be helping to advance scientific knowledge that could lead to better treatments for Parkinson’s disease in the future. Reasonable travel expenses for you and a companion will be reimbursed. The trial uses a single, standard starting dose of atomoxetine, so the chance of side effects is low. If they happen, effects like dry mouth, nausea, slight dizziness, or mild changes in blood pressure are usually mild and wear off within a few hours. Doctors are on hand during testing, and you will receive a 24-hour contact number for peace of mind. Taking part is entirely your choice, and you can withdraw at any point without it affecting your routine NHS care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Cambridge
Unverified
Cambridge, England
Addenbrooke's Clinical Research Centre NIHR/Wellcome Trust Clinical Research Facility & NIHR Clinical Investigation Ward
Unverified
Cambridge, England

Common questions

Will taking this medicine improve my Parkinson’s symptoms permanently?

No. You will only receive a single dose of the medicine during the study. It is designed to help researchers measure short-term effects on thinking, not to provide a lasting treatment.

Do I have to pay anything to take part?

No. The study is completely free, and your travel expenses (as well as those for someone accompanying you) will be refunded.

Do I need to be good with computers to do the tests?

Not at all. The computer tasks are very simple, involving looking at shapes or symbols and pressing buttons. Staff will guide you through practice rounds first.

Can I drive myself home after the hospital visits?

No. As a safety precaution, you must not drive or operate dangerous machinery for the rest of the day after taking the study tablet.

What happens if I decide I want to stop?

You are free to leave the study at any time, for any reason. Doing so will not affect your relationship with your healthcare team or your regular medical care.

How to find out more

Claire O'Callaghan

claire.ocallaghan@sydney.edu.au +61 (02) 9351 0702 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.