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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Australia
University of Queensland Centre for Clinical Research
RECRUITING
Brisbane
Time Frame
Start Date: 2021-02-09
Estimated Completion Date: 2025-12
Participants
Target number of participants: 28
Treatments
Experimental: Active arm
125mg Levetiracetam capsules taken twice daily (morning and evening) for 14 days
Placebo_comparator: Placebo arm
125mg maize starch-based placebo capsules taken twice daily (morning and evening) for 14 days
Sponsors
Leads: The University of Queensland
Collaborators: Royal Brisbane and Women's Hospital, Johns Hopkins University, Cleveland Clinic Lou Ruvo Center for Brain Health, Queensland University of Technology

This content was sourced from clinicaltrials.gov