Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease

Phase 2

Recruiting

• Conditions: Memory Impairment; Parkinson Disease; Mild Cognitive Impairment
• Interventions: Drug: Placebo; Drug: Levetiracetam

• Registration Number: NCT04643327
• Lead Sponsor: The University of Queensland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-25
• Study Start: 2021-02-09
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-04
• Primary Completion: 2023-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo arm	Placebo	125mg maize starch-based placebo capsules taken twice daily (morning and evening) for 14 days
Active arm	Levetiracetam	125mg Levetiracetam capsules taken twice daily (morning and evening) for 14 days

Primary Outcome Measures

Name	Time	Method
Hippocampal DG/CA3 subfield activity	Immediately after 2 weeks of treatment	Participants' brain activation during the pattern separation fMRI paradigm, as measured by their activation in the critical dentate gyrus (DG)/CA3 subfield of the hippocampus during the critical "lure" trials of the pattern separation task.
Pattern separation performance (behavioural outcome)	Immediately after 2 weeks of treatment	Participants' behavioural performance on the pattern separation fMRI paradigm, as measured by their proportionate accuracy of identifying the critical "lure" trials.

Trial Locations

Locations (1)

University of Queensland Centre for Clinical Research; 🇦🇺 Brisbane, Queensland, Australia