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NCT Number: NCT04643327

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Memory Disorders Memory Impairment Mental Disorders Mild Cognitive Impairment Movement Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Queensland Centre for Clinical Research

Brisbane, Queensland, 4029, Australia

Location status: Recruiting

Location contact

Dana Pourzinal, BSc

CONTACT

[email protected]

0733465028

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levetiracetam

Drug

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.

Placebo

Drug

Placebo intervention will be maize-starch filled capsules with identical physical features to the active capsules.

Primary outcomes

  1. Pattern separation performance (behavioural outcome)

    Time frame: 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.

  2. Hippocampal DG/CA3 subfield activity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Queensland

Other

Collaborators

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

Registry information

Official study title

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

Acronym: TRIP

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2020
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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