Testing a new treatment 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
This study is testing if a low dose of an anti-epileptic drug can help reduce memory problems in people with Parkinson's disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Sex | All |
| Sponsor | The University of Queensland Academic / other |
| Locations | 1 site (Brisbane, Queensland) |
| Trial ID | NCT04643327 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of low doses of levetiracetam, an anti-epileptic drug, in addressing memory issues associated with Parkinson's disease. The study will utilize neuroimaging techniques to assess the impact of the drug on specific brain regions, particularly the hippocampal subfields. Additionally, it will compare brain activity between Parkinson's patients with and without memory problems, as well as healthy older adults, to identify predictive markers for memory impairment in Parkinson's disease. This proof-of-concept trial could pave the way for future targeted therapies.
Who should consider this trial
Good fit: Ideal candidates include Parkinson's disease patients with mild cognitive impairment, those without memory impairment, and healthy volunteers eligible for MRI scans.
Not a fit: Patients with dementia or significant non-Parkinson's neurological diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for memory impairment in patients with Parkinson's disease.
How similar studies have performed: While this approach is novel, similar studies targeting cognitive impairment in neurodegenerative diseases have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brisbane, Queensland
- University of Queensland Centre for Clinical Research — Brisbane, Queensland, Australia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.