RECRUITING

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

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Conditions

Parkinson Disease Psychosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-09-28
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05824728

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Use of anticonvulsant medications within 1 month prior to the baseline visit.
  2. 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. 3. History of hypersensitivity or lack of tolerability to AGB101 (levetiracetam).
  4. 4. Severe renal impairment (creatinine clearance of \< 30 mL/minute) or undergoing hemodialysis.
  5. 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. 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. 7. Prior diagnosis of schizophrenia, bipolar disorder or other psychotic disorder other than PD-related psychosis.
  8. 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. 9. History of alcohol or substance abuse or dependence within the past 3 years (DSM-5 criteria).
  10. 10. Any significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol requirements.
  11. 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. 12. Unable or unwilling to provide informed consent or to comply with study procedures.
  13. 13. Patient or caregiver unable to administer daily oral dosing of study drug.
  14. 14. Current suicidal ideation.
  15. 15. Female subjects must not be pregnant or lactating.
  16. 16. Any other reason, which in the opinion of the investigator would confound proper interpretation of the study.

Contacts and Locations

Study Contact

Caroline L Wagandt, BA
CONTACT
410-955-5057
cspeck1@jhmi.edu
Arnold Bakker, PhD
CONTACT
410-502-6944
abakker@jhu.edu

Principal Investigator

Arnold Bakker, Ph.D.
STUDY_DIRECTOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Arnold Bakker, Ph.D., STUDY_DIRECTOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-28
Study Completion Date2026-09

Study Record Updates

Study Start Date2023-09-28
Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

  • Parkinson Disease Psychosis