Actively Recruiting
Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis
Led by Johns Hopkins University · Updated on 2025-10-14
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
A
AgeneBio
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether AGB101, a low-dose extended release levetiracetam tablet, can improve symptoms of psychosis in people with Parkinson's disease. The study addresses how hallucinations and memory problems in Parkinson's disease may relate to similar brain changes found in schizophrenia, focusing on the hippocampus as a shared area of dysfunction. The trial aims to assess if AGB101 can help with psychosis symptoms in Parkinson's disease, with oversight from Johns Hopkins University. Participants will take both AGB101 and a placebo in a randomized order, each for 6 weeks with a 4-week break in between. The study involves two groups: one starts with AGB101 followed by placebo, and the other starts with placebo followed by AGB101. The medication is taken once daily as a tablet. This phase 2 clinical trial includes multiple in-person visits and uses brain imaging and other tests to monitor effects. During the approximately 20-week study, participants will complete up to five visits involving physical and neurological exams, questionnaires, cognitive tests, blood and urine sample collections, and two MRI scans. Researchers will measure changes in hallucinations and delusions using a specialized scale for Parkinson's disease psychosis, alongside brain activity changes detected by fMRI. Safety and symptom monitoring occur at regular intervals throughout the study.
CONDITIONS
Brief Title
Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 85 years inclusive
- Good general health and able to consent and participate for the study duration
- At least eighth-grade education or adequate work history
- Adequate visual and auditory ability for neuropsychological tests
- Proficient fluency in the local language for testing
- Have a study partner with at least 2 hours of weekly contact to assist and provide assessments
- Diagnosed with Parkinson disease psychosis per NINDS/NIMH criteria including hallucinations, delusions, illusions, or false sense of presence
- Symptoms occur after Parkinson's disease onset and recur for at least 1 month
- Symptoms not better explained by other neurological or psychiatric conditions
- Experiencing psychosis symptoms at least once a week during the 4 weeks before screening
- Off treatment for psychosis symptoms for at least 2 weeks before randomization
- On stable Parkinson's disease medication for at least 4 weeks before randomization
- Stable doses of permitted medications (e.g., cholinesterase inhibitors, memantine, antidepressants, antipsychotics) for at least 1 month prior
- Willing and able to undergo repeated MRI scans without contraindications
- Participant and partner willing to use effective contraception during and for 4 days after the study
You will not qualify if you...
- Use of anticonvulsant medications within 1 month before baseline
- Participation in any other therapeutic clinical study within 1 month before screening or during this study
- History of hypersensitivity or intolerance to AGB101 (levetiracetam)
- Severe kidney impairment or undergoing dialysis
- Delirium due to acute metabolic or other causes
- Other neurological disorders that could interfere with the study (e.g., Alzheimer's, multiple sclerosis, seizure disorder history except infant febrile seizures)
- Prior diagnosis of schizophrenia, bipolar disorder, or other psychotic disorders not related to Parkinson's
- Presence of contraindications to MRI such as metal implants or devices
- History of alcohol or substance abuse in past 3 years
- Significant systemic or unstable medical conditions affecting study participation
- Unable or unwilling to consent or comply with study procedures
- Patient or caregiver unable to administer daily oral study drug
- Current suicidal ideation
- Pregnant or lactating females
- Any other condition that might interfere with study interpretation as judged by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks total (6 weeks treatment, 4 weeks washout, 6 weeks treatment)
Participants receive AGB101 or placebo once daily for 6 weeks, followed by a 4-week washout, then cross over to the alternate treatment for another 6 weeks.
Visits at Baseline, Week 3, Week 6, Week 13, and Week 16
Trial Site Locations
Total: 1 location
1
Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
C
Caroline L Wagandt, BA
A
Arnold Bakker, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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