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

Phase 2RecruitingNCT04643327

The University of Queensland28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Parkinson Disease Mild Cognitive Impairment Memory Impairment

Interventions

LevetiracetamDRUG

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.

PlaceboDRUG

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

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 treatment

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.