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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis

Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis (NCT05824728) is a Phase 2 interventional studying Parkinson Disease Psychosis, sponsored by Johns Hopkins University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Parkinson Disease Psychosis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Subjects must meet all of the following inclusion criteria at screening: 1. Subjects between 40 and 85 years old (inclusive) in good general health: 1. Willing and able to consent and participate for the duration of the study. 2. Have eighth-grade education or good work history sufficient to exclude mental retardation. 3. Have visual and auditory acuity adequate for neuropsychological testing. 4. Have proficient fluency of the native local language to participate in all the neuropsychological test assessments. 2. Have a study partner who has sufficient contact (≥ 2 hours per week) with the subject to assist with dosing of study medication (if necessary) and provide assessments of any changes and an independent evaluation of the subject's functioning. 3. Have PDP as defined by all of the following criteria and consistent with the National Institute of Neurological Disorders and Stroke/National Institute of Mental Health (NINDS/NIMH) criteria: 1. Meets United Kingdom brain bank criteria for PD 2. Presence of at least one of the following symptoms - Illusions - False sense of presence - Hallucinations - Delusions 3. The symptoms of Criterion b occur after the onset of PD. 4. The symptoms of Criterion b are recurrent or continuous for 1 month. 5. The symptoms of Criterion b are not better accounted for by another cause of Parkinsonism such as dementia with Lewy bodies, psychiatric disorders such as schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features, or a general medical condition including delirium. 6. May have the following associated features: - With/without insight - With/without dementia - With/without treatment for PD 4. Patients must be experiencing symptom(s) of Criterion 3b at least once a week during the 4 weeks prior to the screening visit. 5. Patients being treated for symptom(s) of Criterion 3b must be off medication for at least 2 weeks prior to randomization. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Subjects must meet all of the following inclusion criteria at screening: 1. Subjects between 40 and 85 years old (inclusive) in good general health: 1. Willing and able to consent and participate for the duration of the study. 2. Have eighth-grade education or good work history sufficient to exclude mental retardation. 3. Have visual and auditory acuity adequate for neuropsychological testing. 4. Have proficient fluency of the native local language to participate in all the neuropsychological test assessments. 2. Have a study partner who has sufficient contact (≥ 2 hours per week) with the subject to assist with dosing of study medication (if necessary) and provide assessments of any changes and an independent evaluation of the subject's functioning. 3. Have PDP as defined by all of the following criteria and consistent with the National Institute of Neurological Disorders and Stroke/National Institute of Mental Health (NINDS/NIMH) criteria: 1. Meets United Kingdom brain bank criteria for PD 2. Presence of at least one of the following symptoms * Illusions * False sense of presence * Hallucinations * Delusions 3. The symptoms of Criterion b occur after the onset of PD. 4. The symptoms of Criterion b are recurrent or continuous for 1 month. 5. The symptoms of Criterion b are not better accounted for by another cause of Parkinsonism such as dementia with Lewy bodies, psychiatric disorders such as schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features, or a general medical condition including delirium. 6. May have the following associated features: * With/without insight * With/without dementia * With/without treatment for PD 4. Patients must be experiencing symptom(s) of Criterion 3b at least once a week during the 4 weeks prior to the screening visit. 5. Patients being treated for symptom(s) of Criterion 3b must be off medication for at least 2 weeks prior to randomization. 6. Patients must be on a stable regimen of medication for PD for at least 4 weeks prior to randomization. 7. Permitted medications: 1. With potential pro-cognitive effects, such as cholinesterase inhibitors, memantine, estrogen replacement therapy, must be at a stable dose for 1 month prior to screening and expected to remain stable throughout the study 2. Antidepressants must be at a stable dose for 1 month prior to screening and expected to remain stable throughout the study. 3. Antipsychotics must be must be at a stable dose for 1 month prior to screening and expected to remain stable throughout the study. 8. Willing and able to undergo repeated MRI scans (3 Tesla) with no contraindications to MRI. 9. Participant and partner must both be willing to use an effective contraception for duration of the study and for 4 days after it. For women, effective contraception may be hormonal; for men, a condom. Exclusion Criteria: Subjects must not meet any of the following exclusion criteria at screening: 1. Use of anticonvulsant medications within 1 month prior to the baseline visit. 2. Participation in a therapeutic clinical study for any medical or psychiatric indications within 1 month of the screening visit, or at any time during the study. Subjects must understand that they may only enroll in this clinical study once; they may not enroll in any other clinical study while participating in the current study, and they may not participate in a clinical study of a drug, biologic, therapeutic device, or medical food, in which the last dose/administration was received within 1 month prior to screening. 3. History of hypersensitivity or lack of tolerability to AGB101 (levetiracetam). 4. Severe renal impairment (creatinine clearance of \< 30 mL/minute) or undergoing hemodialysis. 5. Delirium due to the presence of an acute metabolic encephalopathy secondary to infection or from any other cause as assessed by the investigator based on labs, history, and physical exam. 6. Neurological disorder other than Parkinson's disease, such as Alzheimer's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder (lifetime history; infant febrile seizures are not exclusionary), subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities, that in the opinion of the investigator might interfere with the conduct of the study. 7. Prior diagnosis of schizophrenia, bipolar disorder or other psychotic disorder other than PD-related psychosis. 8. Stereotactic surgery for deep brain stimulation (DBS), presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body that constitute a contraindication to having an MRI scan. 9. History of alcohol or substance abuse or dependence within the past 3 years (DSM-5 criteria). 10. Any significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol requirements. 11. Any unstable medical condition that is likely to require new medical or surgical treatment during the course of the study and where such treatments might affect the collection of efficacy data. 12. Unable or unwilling to provide informed consent or to comply with study procedures. 13. Patient or caregiver unable to administer daily oral dosing of study drug. 14. Current suicidal ideation. 15. Female subjects must not be pregnant or lactating. 16. Any other reason, which in the opinion of the investigator would confound proper interpretation of the study.

Treatments Being Tested

DRUG

AGB101

low-dose levetiracetam, 220 mg, extended release tablet

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Johns Hopkins
Baltimore, Maryland, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05824728), the sponsor (Johns Hopkins University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05824728 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05824728?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05824728?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05824728. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05824728. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.