TRIP Clinical Trial: Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson’s disease
Cognitive impairment and dementia are a top concern for people living with Parkinson’s disease (PD). The TRIP study explores a potential treatment for mild memory impairment with the overall aim of reducing dementia risk in Parkinson’s disease.
Why do we care about memory in Parkinson's Disease?
While it is well known that people with PD experience problems with their movement (such as tremors, stiffness, slowness, and loss of balance), other aspects of the disease are often under-researched. This is especially true of the cognitive symptoms, such as memory problems, that many people with PD experience.
In fact, we now know that cognition is the top concern of people with PD, and that even mild memory problems can be present at the time of PD diagnosis. Decline in memory can also contribute towards a poor quality of life for people with PD.
Research conducted at Johns Hopkins University in the U.S.A has shown evidence for low doses of the drug levetiracetam in reducing memory problems in people with mild memory deficits prior to developing Alzheimer’s disease.
Currently, levetiracetam is the subject of a Food & Drug Administration (FDA)- registered phase III clinical trial to treat mild memory impairment in the U.S.A.
Levetiracetam is approved in Australia to treat epilepsy. It is currently prescribed to many Australians over the age of four to prevent epileptic seizures. However, it is not approved in Australia to treat memory impairments in PD.
What are we trying to achieve?
The aim of the present study is to test whether low doses of levetiracetam can reduce mild memory problems in people with PD. By adopting the approach developed by the team at Johns Hopkins University, we hope to discover:
a) Whether levetiracetam is able to improve memory in people with PD who experience mild memory problems; and
b) The mechanism of the study drug (Levetiracetam) on the brain via brain imaging.
Who can participate?
If you are living with Parkinson’s disease and are eligible for an MRI scan, we invite you to participate. If you’re not sure if you are eligible for an MRI scan, that’s not a problem. We will do an inital screen to check your eligibility for our study.
We also invite older adults who do not have a diagnosis of Parkinson’s disease and who are eligible for an MRI scan to participate as a comparison group.
Unfortunately, people with a current diagnosis of dementia are ineligible for this study.
Participation in our study is voluntary, and you may withdraw at any point.
What would be required of you?
Depending on whether you have Parkinson’s disease and whether you are experiencing mild memory problems, you will be required to complete different study activities.
For older adults without Parkinson’s disease and those living with Parkinson’s disease and NO memory problems, you will be invited to:
- Fill out an online questionnaire
- Complete two in-person screening interviews (Interview I may be completed via teleconference)
- Have an MRI scan of the head while completing a memory task
For those living with Parkinson’s disease WITH memory problems, you will be invited to:
- Fill out an online questionnaire
- Complete two in-person screening interviews (Interview I may be completed via teleconference)
- Have a medical assessment, including bloodwork
- Take one set of medication twice daily for 14 days, followed by an MRI scan of the head while completing a memory task
- Have a four-week rest period with no study drugs
- Take another set of medication twice daily for 14 days, followed by an MRI scan of the head while completing a memory task
What about COVID-19? Will it affect the trial?
We have made some important adjustments to how we conduct the study to combat the risk of COVID-19.
Depending on your circumstances and available equipment, we will be able to conduct parts of our interviews via teleconference to minimise the number of visits you are required to make to our UQ Centre. Strict COVID-19 protocols are in place to minimise risks during the visits for the assessment interviews and MRI.