AGB101 for Parkinson's (NCT05824728)
Reduce hallucinations delusions and illusions
- Trial ID
- NCT05824728
- Official Title
- Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis
- Goal
- Reduce hallucinations delusions and illusions
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Johns Hopkins University
- Study Type
- INTERVENTIONAL
- Enrollment
- 30 participants
- Conditions
- Parkinson Disease Psychosis
- Interventions
- AGB101
Summary For Families
AGB101 is being tested to see if low-dose levetiracetam 220 mg in an extended-release tablet can help psychosis symptoms in Parkinson's disease, like hallucinations, a false sense of someone being present, illusions, or delusions. Participants will take AGB101 and a matching placebo once a day for six weeks each, with a four-week break between treatments, and will come for up to five in-person visits over about 20 weeks for exams, questionnaires and paper-and-pencil tests, blood and urine samples, and two magnetic resonance imaging scans. The Phase 2 trial plans to enroll about 30 people. They are looking for adults 40 to 85 who have Parkinson's-related psychosis at least once a week, who have a study partner who sees them at least 2 hours a week, can undergo magnetic resonance imaging, are on stable Parkinson's medicines, and can stop other antipsychotic or anti-seizure medicines if required; people with severe kidney problems, a past diagnosis of schizophrenia or bipolar disorder, recent use of anti-seizure drugs, or implants that make magnetic resonance imaging unsafe are not eligible.
Locations
- Johns Hopkins, Baltimore, Maryland, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying AGB101. AGB101 is being tested to see if low-dose levetiracetam 220 mg in an extended-release tablet can help psychosis symptoms in Parkinson's disease, like hallucinations, a false sense of someone being present, illusions, or delusions. Participants will take AGB101 and a matching placebo once a day for six weeks each, with a four-week break between treatments, and will come for up to five in-person visits over about 20 weeks for exams, questionnaires and paper-and-pencil tests, blood and urine samples, and two magnetic resonance imaging scans. The Phase 2 trial plans to enroll about 30 people. They are looking for adults 40 to 85 who have Parkinson's-related psychosis at least once a week, who have a study partner who sees them at least 2 hours a week, can undergo magnetic resonance imaging, are on stable Parkinson's medicines, and can stop other antipsychotic or anti-seizure medicines if required; people with severe kidney problems, a past diagnosis of schizophrenia or bipolar disorder, recent use of anti-seizure drugs, or implants that make magnetic resonance imaging unsafe are not eligible.
- Who can participate?
- Participants must be between 40 Years and 85 Years.
- 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 2 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.
- How many visits does this trial involve?
- You will complete up to 5 in-person study visits over approximately 20 weeks.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: MRI scan (non-invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.
- Is there a medication washout in this trial?
- There is a 4-week washout period between treatment periods.