Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease
NCT ID: NCT04643327
Last Updated: 2024-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
28 participants
INTERVENTIONAL
2021-02-09
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Active arm
125mg Levetiracetam capsules taken twice daily (morning and evening) for 14 days
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 arm
125mg maize starch-based placebo capsules taken twice daily (morning and evening) for 14 days
Placebo
Placebo intervention will be maize-starch filled capsules with identical physical features to the active capsules.
Interventions
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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
Placebo intervention will be maize-starch filled capsules with identical physical features to the active capsules.
Eligibility Criteria
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Inclusion Criteria
* Parkinson's Disease patients with no memory impairment
* Healthy volunteers
* All participants must be eligible to take MRI scans
Exclusion Criteria
* 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
ALL
Yes
Sponsors
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Queensland University of Technology
OTHER
Johns Hopkins University
OTHER
Cleveland Clinic Lou Ruvo Center for Brain Health
UNKNOWN
Royal Brisbane and Women's Hospital
OTHER_GOV
The University of Queensland
OTHER
Responsible Party
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Nadeeka Dissanyaka
NHMRC Boosting Dementia Research Leadership Fellow
Locations
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University of Queensland Centre for Clinical Research
Brisbane, Queensland, Australia
Countries
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Facility Contacts
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References
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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.
Other Identifiers
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HREC/2020/QRBW/69379
Identifier Type: -
Identifier Source: org_study_id
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