Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease (TRIP)
Primary Purpose
Parkinson Disease, Mild Cognitive Impairment, Memory Impairment
Status
Recruiting
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Levetiracetam
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility 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
Sites / Locations
- University of Queensland Centre for Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active arm
Placebo arm
Arm Description
125mg Levetiracetam capsules taken twice daily (morning and evening) for 14 days
125mg maize starch-based placebo capsules taken twice daily (morning and evening) for 14 days
Outcomes
Primary Outcome Measures
Pattern separation performance (behavioural outcome)
Participants' behavioural performance on the pattern separation fMRI paradigm, as measured by their proportionate accuracy of identifying the critical "lure" trials.
Hippocampal DG/CA3 subfield activity
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04643327
First Posted
November 18, 2020
Last Updated
November 2, 2022
Sponsor
The University of Queensland
Collaborators
Queensland University of Technology, Johns Hopkins University, Cleveland Clinic Lou Ruvo Center for Brain Health, Royal Brisbane and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04643327
Brief Title
Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease
Acronym
TRIP
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Queensland
Collaborators
Queensland University of Technology, Johns Hopkins University, Cleveland Clinic Lou Ruvo Center for Brain Health, Royal Brisbane and Women's Hospital
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Mild Cognitive Impairment, Memory Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Double-blind randomised-controlled within-subject crossover trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active arm
Arm Type
Experimental
Arm Description
125mg Levetiracetam capsules taken twice daily (morning and evening) for 14 days
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
125mg maize starch-based placebo capsules taken twice daily (morning and evening) for 14 days
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo intervention will be maize-starch filled capsules with identical physical features to the active capsules.
Primary Outcome Measure Information:
Title
Pattern separation performance (behavioural outcome)
Description
Participants' behavioural performance on the pattern separation fMRI paradigm, as measured by their proportionate accuracy of identifying the critical "lure" trials.
Time Frame
Immediately after 2 weeks of treatment
Title
Hippocampal DG/CA3 subfield activity
Description
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.
Time Frame
Immediately after 2 weeks of treatment
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University of Queensland Centre for Clinical Research
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Pourzinal, BSc
Phone
0733465028
Email
pd.research@uq.edu.au
12. IPD Sharing Statement
Learn more about this trial
Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease
We'll reach out to this number within 24 hrs