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
Plain-Language Summary
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.