Memory Impairment, Mild Cognitive Impairment, Parkinson Disease
Conditions
Brief summary
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.
Interventions
DRUGLevetiracetam
Levetiracetam 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.
DRUGPlacebo
Placebo intervention will be maize-starch filled capsules with identical physical features to the active capsules.
Sponsors
Queensland University of Technology
Johns Hopkins University
Cleveland Clinic Lou Ruvo Center for Brain Health
Royal Brisbane and Women's Hospital
The University of Queensland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double-blind randomised-controlled within-subject crossover trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Dementia * Contraindication to having MRI * Bipolar disorder, Schizophrenia, Alcohol or substance abuse * Major depression * Suicidal Ideation * Difficulty complying with protocol requirements * Significant non-PD neurological disease * Vascular dementia * Sensitivity to levetiracetam * Use of anticonvulsant medications * Use of other excluded medications * Severe renal impairment * Clinically significant abnormalities in B12 or thyroid function test (below normative range for elderly) * Females of childbearing potential
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pattern separation performance (behavioural outcome) | Immediately after 2 weeks of treatment | Participants' behavioural performance on the pattern separation fMRI paradigm, as measured by their proportionate accuracy of identifying the critical lure trials. |
| Hippocampal DG/CA3 subfield activity | Immediately after 2 weeks of treatment | 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. |
Countries
Australia
Outcome results
None listed