RECRUITINGPhase 2INTERVENTIONAL

Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease

Double-blind Randomised-controlled Within-subject Crossover Trial to Determine Levetiracetam Efficacy for Memory Impairment in Parkinson's Disease: A Proof-of-concept Study

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Levetiracetam

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.

DRUG

Placebo

Placebo intervention will be maize-starch filled capsules with identical physical features to the active capsules.

Locations (1)

University of Queensland Centre for Clinical Research

Brisbane, Queensland, Australia