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

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ClinicalTrials.gov Identifier: NCT04643327
Recruitment Status : Recruiting
First Posted : November 25, 2020
Last Update Posted : May 3, 2021
Sponsor:
Collaborators:
Queensland University of Technology
Johns Hopkins University
Cleveland Clinic Lou Ruvo Center for Brain Health
Royal Brisbane and Women's Hospital
Information provided by (Responsible Party):
Nadeeka Dissanyaka, 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Mild Cognitive Impairment Memory Impairment Drug: Levetiracetam Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double-blind randomised-controlled within-subject crossover trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : February 9, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active arm
125mg Levetiracetam capsules taken twice daily (morning and evening) for 14 days
Drug: Levetiracetam
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 Comparator: Placebo arm
125mg maize starch-based placebo capsules taken twice daily (morning and evening) for 14 days
Drug: Placebo
Placebo intervention will be maize-starch filled capsules with identical physical features to the active capsules.




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04643327


Locations
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Australia, Queensland
University of Queensland Centre for Clinical Research Recruiting
Brisbane, Queensland, Australia, 4029
Contact: Dana Pourzinal, BSc    0733465028    pd.research@uq.edu.au   
Sponsors and Collaborators
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
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Responsible Party: Nadeeka Dissanyaka, NHMRC Boosting Dementia Research Leadership Fellow, The University of Queensland
ClinicalTrials.gov Identifier: NCT04643327    
Other Study ID Numbers: HREC/2020/QRBW/69379
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Parkinson Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Levetiracetam
Anticonvulsants
Nootropic Agents