RecruitingPhase 2NCT04643327

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

Sponsor

The University of Queensland

Enrollment

28 participants

Start Date

Feb 9, 2021

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease Mild Cognitive Impairment Memory Impairment

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.

Eligibility

Inclusion Criteria4

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 Criteria14

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

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.