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

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

Plain Language Summary

Simplified for easier understanding

This study is investigating a new treatment approach to reduce the risk of developing dementia in people with Parkinson's disease. Researchers are looking at whether a medication called levetiracetam (typically used for epilepsy) can target a specific brain mechanism linked to memory decline in Parkinson's, using brain MRI scans to track changes. **You may be eligible if...** - You have Parkinson's disease — with or without mild memory problems - You are able to have an MRI scan - Healthy volunteers without Parkinson's or memory problems are also eligible for comparison **You may NOT be eligible if...** - You already have full dementia - You have a metal implant or other reason you cannot have an MRI - You have bipolar disorder, schizophrenia, or major depression - You have had suicidal thoughts - You have severe kidney problems - You are sensitive to levetiracetam or take anticonvulsant medications - You are a woman of childbearing potential - You have significant abnormalities in B12 or thyroid levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

University of Queensland Centre for Clinical Research

Brisbane, Queensland, Australia

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NCT04643327


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