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

Sponsor
The University of Queensland (Other)
Overall Status
Recruiting
CT.gov ID
NCT04643327
Collaborator
Queensland University of Technology (Other), Johns Hopkins University (Other), Cleveland Clinic Lou Ruvo Center for Brain Health (Other), Royal Brisbane and Women's Hospital (Other)
28
1
2
33.7
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Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Double-blind randomised-controlled within-subject crossover trialDouble-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 :
Feb 9, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Queensland Centre for Clinical Research Brisbane Queensland Australia 4029

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Nov 25, 2020
Last Update Posted:
May 3, 2021
Last Verified:
Apr 1, 2021
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:

Study Results

No Results Posted as of May 3, 2021