Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorThe University of Queensland
About this trial
The present study is a proof-of-concept clinical trial to test the efficacy of low doses of a repurposed anti-epileptic drug (levetiracetam) in treating memory problems in Parkinson's disease (PD). Neuroimaging techniques will be used to determine the effect of the drug on specific brain regions (hippocampal subfields). Finally, baseline brain activity of PD patients with memory problems will be compared to PD patients without memory problems and healthy older adults to determine if activity in specific brain regions (hippocampal subfields) can be used to predict memory problems in PD. This information will be useful for future clinical trials to target drugs to these brain regions.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Parkinson's Disease patients with amnestic Mild Cognitive Impairment
Parkinson's Disease patients with no memory impairment
Healthy volunteers
All participants must be eligible to take MRI scans
Disqualifiers
Dementia
Contraindication to having MRI
Bipolar disorder, Schizophrenia, Alcohol or substance abuse
Major depression
Trial design
Design model
Crossover
Treatments tested in this trial
Levetiracetam
DrugLevetiracetam is currently approved in Australia and the U.S.A. for epilepsy. We will be providing levetiracetam in capsule form, 125mg levetiracetam in each capsule.
Placebo
DrugPlacebo intervention will be maize-starch filled capsules with identical physical features to the active capsules.
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: Active armExperimental treatment 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pattern separation performance (behavioural outcome)
Participants' behavioural performance on the pattern separation fMRI paradigm, as measured by their proportionate accuracy of identifying the critical "lure" trials.
Time frame
Immediately after 2 weeks of treatment2
Hippocampal DG/CA3 subfield activity
Participants' brain activation during the pattern separation fMRI paradigm, as measured by their activation in the critical dentate gyrus (DG)/CA3 subfield of the hippocampus during the critical "lure" trials of the pattern separation task.
Time frame
Immediately after 2 weeks of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Queensland
Lead sponsor
Queensland University of Technology
Collaborator
Johns Hopkins University
Collaborator
Cleveland Clinic Lou Ruvo Center for Brain Health
Collaborator
Royal Brisbane and Women's Hospital
Collaborator
Source ClinicalTrials.gov