Parkinson DiseasePhase 2TRIPNCT04643327
Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease
A Phase 2 study testing Levetiracetam in people with Parkinson Disease and Mild Cognitive Impairment, run by The University of Queensland at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Mild Cognitive Impairment, Memory Impairment
- What is being tested?
- Levetiracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Feb 2021to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Dementia
- Contraindication to having MRI
- Bipolar disorder, Schizophrenia, Alcohol or substance abuse
- Major depression
- Suicidal Ideation
- Difficulty complying with protocol requirements
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- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
University of Queensland Centre for Clinical Research
Brisbane, Queensland, 4029
Dana Pourzinal, BSc, 0733465028, pd.research@uq.edu.au
About this study
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
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.
- Being tested
- Levetiracetam, Placebo
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
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.
PlaceboDrug
Placebo intervention will be maize-starch filled capsules with identical physical features to the active capsules.
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Experimental | 125mg Levetiracetam capsules taken twice daily (morning and evening) for 14 days Receives: Drug: Levetiracetam |
| Placebo arm | Placebo comparator | 125mg maize starch-based placebo capsules taken twice daily (morning and evening) for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after 2 weeks of treatment
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.
Measured: Immediately after 2 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start9 Feb 2021
- Primary completionJan 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind randomised-controlled within-subject crossover trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Queensland University of Technology, Johns Hopkins University, Cleveland Clinic Lou Ruvo Center for Brain Health, Royal Brisbane and Women's Hospital
- Responsible party
- Principal investigator, Nadeeka Dissanyaka, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643327
- Sponsor's protocol ID
- HREC/2020/QRBW/69379
- Acronym
- TRIP
- Status last verified
- Sep 2024
- First submitted
- 18 Nov 2020
- Last updated
- 25 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dissanayaka N, Pourzinal D, Byrne GJ, Yang J, McMahon KL, Pontone GM, O'Sullivan JD, Adam R, Littleford R, Chatfield M, Lehn A, Mari Z, Bakker A. Levetiracetam for the treatment of mild cognitive impairment in Parkinson's disease: a double-blind controlled proof-of-concept trial protocol. Pilot Feasibility Stud. 2023 Nov 22;9(1):189. doi: 10.1186/s40814-023-01406-y.
PubMed 37993889
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04643327
- Acronym / sponsor ID
- TRIP / HREC/2020/QRBW/69379
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Queensland University of Technology, Johns Hopkins University, Cleveland Clinic Lou Ruvo Center for Brain Health, Royal Brisbane and Women's Hospital
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind randomised-controlled within-subject crossover trial
| Arm | Type | Receives |
|---|---|---|
| Active arm | Experimental | Drug: Levetiracetam125mg Levetiracetam capsules taken twice daily (morning and evening) for 14 days |
| Placebo arm | Placebo comparator | Drug: Placebo125mg maize starch-based placebo capsules taken twice daily (morning and evening) for 14 days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Dementia
- Contraindication to having MRI
- Bipolar disorder, Schizophrenia, Alcohol or substance abuse
- Major depression
- Suicidal Ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevetiracetamLevetiracetam 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. | Drug | Active arm |
| PlaceboPlacebo intervention will be maize-starch filled capsules with identical physical features to the active capsules. | Drug | Placebo arm |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Derived from this study: PubMed 37993889Dissanayaka N, Pourzinal D, Byrne GJ, Yang J, McMahon KL, Pontone GM, O'Sullivan JD, Adam R, Littleford R, Chatfield M, Lehn A, Mari Z, Bakker A. Levetiracetam for the treatment of mild cognitive impairment in Parkinson's disease: a double-blind controlled proof-of-concept trial protocol. Pilot Feasibility Stud. 2023 Nov 22;9(1):189. doi: 10.1186/s40814-023-01406-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University of Queensland Centre for Clinical Research
Brisbane, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levetiracetam in people with Parkinson Disease and Mild Cognitive Impairment, run by The University of Queensland at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern separation performance (behavioural outcome) (time frame: Immediately after 2 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04643327, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.