NCT05824728Active, not recruitingPhase 2
Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 6 Apr 2023
- Start date
- 28 Sept 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- Johns Hopkins University
- Diseases
- Parkinson disease
- NCT number
- NCT05824728
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 28 Sept 2023 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of anticonvulsant medications within 1 month prior to the baseline visit.
- 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.
- Prior diagnosis of schizophrenia, bipolar disorder or other psychotic disorder other than PD-related psychosis.
- Patient or caregiver unable to administer daily oral dosing of study drug.
Other illness
- History of hypersensitivity or lack of tolerability to AGB101 (levetiracetam).
- 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.
- 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.
- 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.
- History of alcohol or substance abuse or dependence within the past 3 years (DSM-5 criteria).
- Any significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol requirements.
- 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.
Lab values
- Severe renal impairment (creatinine clearance of \< 30 mL/minute) or undergoing hemodialysis.
Other
- Subjects must not meet any of the following exclusion criteria at screening:
- Unable or unwilling to provide informed consent or to comply with study procedures.
- Current suicidal ideation.
- Female subjects must not be pregnant or lactating.
- Any other reason, which in the opinion of the investigator would confound proper interpretation of the study.
Criteria the registry did not label
- Subjects must meet all of the following inclusion criteria at screening:
- Subjects between 40 and 85 years old (inclusive) in good general health:
- Willing and able to consent and participate for the duration of the study.
- Have eighth-grade education or good work history sufficient to exclude mental retardation.
- Have visual and auditory acuity adequate for neuropsychological testing.
- Have proficient fluency of the native local language to participate in all the neuropsychological test assessments.
- 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.
- 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:
- Meets United Kingdom brain bank criteria for PD
- Presence of at least one of the following symptoms
- Illusions
- False sense of presence
- Hallucinations
- Delusions
- The symptoms of Criterion b occur after the onset of PD.
- The symptoms of Criterion b are recurrent or continuous for 1 month.
- 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.
- May have the following associated features:
- With/without insight
- With/without dementia
- With/without treatment for PD
- Patients must be experiencing symptom(s) of Criterion 3b at least once a week during the 4 weeks prior to the screening visit.
- Patients being treated for symptom(s) of Criterion 3b must be off medication for at least 2 weeks prior to randomization.
- Patients must be on a stable regimen of medication for PD for at least 4 weeks prior to randomization.
- Permitted medications:
- 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
- Antidepressants must be at a stable dose for 1 month prior to screening and expected to remain stable throughout the study.
- Antipsychotics must be must be at a stable dose for 1 month prior to screening and expected to remain stable throughout the study.
- Willing and able to undergo repeated MRI scans (3 Tesla) with no contraindications to MRI.
- 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.
Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.