Levetiracetam for Parkinson's (NCT04643327)
Reduce memory impairment using levetiracetam
- Trial ID
- NCT04643327
- 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
- Goal
- Reduce memory impairment using levetiracetam
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- The University of Queensland
- Study Type
- INTERVENTIONAL
- Enrollment
- 28 participants
- Conditions
- Parkinson Disease, Mild Cognitive Impairment, Memory Impairment
- Interventions
- Levetiracetam, Placebo
Summary For Families
Trying to see whether low-dose levetiracetam can reduce abnormal hippocampal activity and improve memory in people with Parkinson's who have amnestic mild cognitive impairment. Levetiracetam is an anticonvulsant that binds the synaptic vesicle protein SV2A to calm excess neuronal firing and normalize memory encoding, it does not act on dopamine pathways and is not expected to change levodopa metabolism, though it can cause mood or behavioral side effects and should not be used with other anticonvulsants. The trial is a double-blind, randomized within-subject crossover versus placebo with MRI assessments. They want people with Parkinson's with or without memory impairment plus healthy volunteers who can have MRI, and they exclude anyone with dementia, major psychiatric illness, current anticonvulsant use, severe renal impairment, or females of childbearing potential.
Locations
- University of Queensland Centre for Clinical Research, Brisbane, Queensland, Australia
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Levetiracetam. Trying to see whether low-dose levetiracetam can reduce abnormal hippocampal activity and improve memory in people with Parkinson's who have amnestic mild cognitive impairment. Levetiracetam is an anticonvulsant that binds the synaptic vesicle protein SV2A to calm excess neuronal firing and normalize memory encoding, it does not act on dopamine pathways and is not expected to change levodopa metabolism, though it can cause mood or behavioral side effects and should not be used with other anticonvulsants. The trial is a double-blind, randomized within-subject crossover versus placebo with MRI assessments. They want people with Parkinson's with or without memory impairment plus healthy volunteers who can have MRI, and they exclude anyone with dementia, major psychiatric illness, current anticonvulsant use, severe renal impairment, or females of childbearing potential.
- Who can participate?
- Eligibility criteria vary. Check the full listing on ClinicalTrials.gov for detailed inclusion and exclusion criteria.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 3 years and 11 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. It also includes a placebo or sham phase, so you would be on that during another period. Ask the coordinator for the exact sequence and how long each phase lasts.