Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis
Johns Hopkins University
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.
Description
Hallucinations and memory impairment have a parallel clinical course in Parkinson's disease (PD) and are independently associated dysfunction and pathology accumulation in hippocampal subregions. Similar alterations of hippocampal function are found in schizophrenic patients with memory impairment and positive psychotic symptoms. These findings suggest that dysfunction of the hippocampus may be a shared mechanism for memory impairment and psychosis across diseases. This investigation aims to address these questions and assess the efficacy of AGB101 for the treatment of psychosis in PD.
Eligibility
- Age range
- 40–85 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugAGB101
low-dose levetiracetam, 220 mg, extended release tablet
Location
- Johns HopkinsBaltimore, Maryland