NCT04643327

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: The University of Queensland · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Parkinson Disease
• Mild Cognitive Impairment
• Memory Impairment

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-09
• Primary completion: 2025-01-01
• Completion: 2025-12-01
• First posted: 2020-11-25
• Last updated: 2024-09-25

Locations

1 site across 1 country: Australia