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

NCT05824728 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB00318189
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Parkinson Disease Psychosis

Outcome Measures

Primary Outcomes (1)

• Change in hallucinations/delusions as assessed by the Enhanced Scale for Assessment of Positive Symptoms in Parkinson's Disease (eSAPS-PD)

  The eSAPS-PD is used to track changes in hallucinations and other psychotic symptoms over time. It was adapted from the scale for the assessment of positive symptoms (SAPS), which is used to track positive symptoms in patients with schizophrenia. The eSAPS-PD is a 13-item questionnaire which specifically assesses the frequency or severity of the most common types of hallucinations or delusions found in PD, namely auditory hallucinations, voices conversing, somatic or tactile hallucinations, visual hallucinations, persecutory delusions, delusions of jealousy and delusions of reference. In addition, the enhanced version assesses minor psychotic phenomena such as illusions, passage hallucinations, and presence hallucinations. Each item is rated from 0-5, with 0 representing none and 5 representing severe and frequent symptoms, and the total score ranges from 0 to 65.

  Screening, Baseline, Week 3, Week 6, Week 13, Week 16

Secondary Outcomes (1)

• Change in hippocampal overactivity as measured by fMRI (functional Magnetic Resonance Imaging)

  Week 6, Week 16

Study Arms (2)

AGB101 first, then placebo

EXPERIMENTAL

AGB101 (low-dose levetiracetam, 220 mg, extended release tablet) once daily for 6 weeks, washout (4 weeks), then placebo capsule once daily for 6 weeks.

Drug: AGB101

placebo first, then AGB101

EXPERIMENTAL

Placebo capsule once daily for 6 weeks, washout (4 weeks), then AGB101 (low-dose levetiracetam, 220 mg, extended release tablet) once daily for 6 weeks.

Drug: AGB101

Interventions

AGB101 DRUG

low-dose levetiracetam, 220 mg, extended release tablet

Also known as: levetiracetam

AGB101 first, then placebo; placebo first, then AGB101

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• History of hypersensitivity or lack of tolerability to AGB101 (levetiracetam).
• Severe renal impairment (creatinine clearance of \< 30 mL/minute) or undergoing hemodialysis.
• 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.
• Prior diagnosis of schizophrenia, bipolar disorder or other psychotic disorder other than PD-related psychosis.
• 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.
• Unable or unwilling to provide informed consent or to comply with study procedures.
• Patient or caregiver unable to administer daily oral dosing of study drug.
• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• AgeneBio: collaborator

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Interventions

Levetiracetam

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Arnold Bakker, Ph.D.

  Johns Hopkins University

  STUDY DIRECTOR

Central Study Contacts

Caroline L Wagandt, BA

CONTACT

410-955-5057; cspeck1@jhmi.edu

Arnold Bakker, PhD

CONTACT

410-502-6944; abakker@jhu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 24, 2023
• Study Start: September 28, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)