Double-blind Randomised-controlled Within-subject Crossover Trial to Determine Levetiracetam Efficacy for Memory Impairment in Parkinson's Disease: A Proof-of-concept Study

Trial ID: NCT04643327

Interventional - Phase 2 - Unknown status

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

• Levetiracetam
• Placebo

Eligibility

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

Sponsor

The University of Queensland, Queensland University of Technology, Johns Hopkins University, Cleveland Clinic Lou Ruvo Center for Brain Health, Royal Brisbane and Women's Hospital

Source: ClinicalTrials.gov

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