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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 3 years and 11 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.