Reduce hallucinations without worsening movement
- 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 without worsening movement
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Johns Hopkins University
- Study Type
- INTERVENTIONAL
- Enrollment
- 30 participants
- Conditions
- Parkinson Disease Psychosis
- Interventions
- AGB101
Summary For Families
The team is testing whether AGB101, a formulation of levetiracetam, can reduce hallucinations, delusions, and other psychosis symptoms that arise after Parkinson's onset without making motor symptoms worse. AGB101 binds the synaptic vesicle protein SV2A to calm abnormal neuronal hyperexcitability, and because it is not a dopamine blocker it is not expected to interfere with levodopa's benefits. They are enrolling people 40 to 85 years old with Parkinson's disease who have recurrent psychosis at least once a week, who have a study partner, can have repeated MRIs, are on stable PD meds for at least 4 weeks and off antipsychotics for 2 weeks; key exclusions include severe kidney impairment, prior levetiracetam intolerance, other major neurologic or psychotic disorders, or MRI-incompatible implants.
Locations
- Johns Hopkins, Baltimore, Maryland, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying AGB101. The team is testing whether AGB101, a formulation of levetiracetam, can reduce hallucinations, delusions, and other psychosis symptoms that arise after Parkinson's onset without making motor symptoms worse. AGB101 binds the synaptic vesicle protein SV2A to calm abnormal neuronal hyperexcitability, and because it is not a dopamine blocker it is not expected to interfere with levodopa's benefits. They are enrolling people 40 to 85 years old with Parkinson's disease who have recurrent psychosis at least once a week, who have a study partner, can have repeated MRIs, are on stable PD meds for at least 4 weeks and off antipsychotics for 2 weeks; key exclusions include severe kidney impairment, prior levetiracetam intolerance, other major neurologic or psychotic disorders, or MRI-incompatible implants.
- 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?
- 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 2 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.