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
152 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
A
AgeneBio
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial will test whether AGB101 (low-dose levetiracetam, 220 mg, extended release tablet) can improve symptoms of psychosis in Parkinson's disease. Participants will be asked to complete up to 5 in-person study visits over approximately 20 weeks. Participants will receive both AGB101 and a placebo to take once a day for 6 weeks, with a 4-week washout in between. Participation will also involve physical/neurological exams, questionnaires, paper and pencil tests, providing blood and urine samples, and completing two MRI exams.
CONDITIONS
Official 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 old inclusive and in good general health
- Willing and able to consent and participate for the entire study duration
- At least eighth-grade education or equivalent work history to exclude mental retardation
- Adequate visual and auditory ability for neuropsychological testing
- Proficient in the native language to complete neuropsychological assessments
- Have a study partner with at least 2 hours of weekly contact to assist with medication and evaluations
- Diagnosed with Parkinson's disease psychosis meeting NINDS/NIMH criteria, including Parkinson's diagnosis, psychosis symptoms (illusions, false presence, hallucinations, or delusions) occurring after PD onset and lasting at least 1 month
- Psychosis symptoms occur at least once per week in the 4 weeks before screening
- Off medication for psychosis symptoms for at least 2 weeks before randomization if treated
- On a stable Parkinson's disease medication regimen for at least 4 weeks before randomization
- Stable doses of permitted medications (cholinesterase inhibitors, memantine, estrogen, antidepressants, antipsychotics) for at least 1 month prior to screening
- Willing and able to undergo repeated 3 Tesla MRI scans without contraindications
- Participant and partner agree to use effective contraception during the study and for 4 days after (hormonal for women, condom for men)
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 dialysis
- Delirium from acute metabolic encephalopathy or infection
- Other neurological disorders that might interfere with the study, including Alzheimer's, Huntington's, multiple sclerosis, seizure disorders (except infant febrile seizures), brain tumors, or significant head trauma
- Prior diagnosis of schizophrenia, bipolar disorder, or other psychotic disorders unrelated to Parkinson's disease
- Presence of medical devices or implants that prevent MRI scans
- History of alcohol or substance abuse in the past 3 years
- Any significant or unstable medical condition that could affect study compliance or data collection
- Unable or unwilling to provide informed consent or follow study procedures
- Patient or caregiver unable to manage daily oral dosing
- Current suicidal thoughts
- Female participants who are pregnant or breastfeeding
- Any other condition that might impact proper study interpretation as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
C
Caroline L Wagandt, BA
CONTACT
A
Arnold Bakker, PhD
CONTACT
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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