NCT04643327 Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease
| NCT ID | NCT04643327 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The University of Queensland |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2021-02-09 |
| Primary Completion | 2025-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 28 participants in total. It began in 2021-02-09 with a primary completion date of 2025-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Frequently Asked Questions
Who can join the NCT04643327 clinical trial?
This trial is open to participants of all sexes, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04643327 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04643327 currently recruiting?
Yes, NCT04643327 is actively recruiting participants. Visit ClinicalTrials.gov or contact The University of Queensland to inquire about joining.
Where is the NCT04643327 trial being conducted?
This trial is being conducted at Brisbane, Australia.
Who is sponsoring the NCT04643327 clinical trial?
NCT04643327 is sponsored by The University of Queensland. The trial plans to enroll 28 participants.
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