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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04643327
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04643327