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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04643327




Registration number
NCT04643327
Ethics application status
Date submitted
18/11/2020
Date registered
25/11/2020
Date last updated
4/11/2022

Titles & IDs
Public title
Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease
Scientific 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
Secondary ID [1] 0 0
HREC/2020/QRBW/69379
Universal Trial Number (UTN)
Trial acronym
TRIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson Disease 0 0
Mild Cognitive Impairment 0 0
Memory Impairment 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Levetiracetam
Treatment: Drugs - Placebo

Experimental: Active arm - 125mg Levetiracetam capsules taken twice daily (morning and evening) for 14 days

Placebo comparator: Placebo arm - 125mg maize starch-based placebo capsules taken twice daily (morning and evening) for 14 days


Treatment: Drugs: 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.

Treatment: Drugs: Placebo
Placebo intervention will be maize-starch filled capsules with identical physical features to the active capsules.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pattern separation performance (behavioural outcome)
Timepoint [1] 0 0
Immediately after 2 weeks of treatment
Primary outcome [2] 0 0
Hippocampal DG/CA3 subfield activity
Timepoint [2] 0 0
Immediately after 2 weeks of treatment

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
University of Queensland Centre for Clinical Research - Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Queensland University of Technology
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Johns Hopkins University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Cleveland Clinic Lou Ruvo Center for Brain Health
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
Royal Brisbane and Women's Hospital
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04643327