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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
low-dose levetiracetam, 220 mg, extended release tablet
Johns Hopkins
Baltimore, Maryland, United States
RECRUITINGChange 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.
Time frame: Screening, Baseline, Week 3, Week 6, Week 13, Week 16
Change in hippocampal overactivity as measured by fMRI (functional Magnetic Resonance Imaging)
The secondary efficacy evaluation is confirmation of target engagement demonstrated by reduction in hippocampal overactivity comparing the end of the active treatment period compared to the end of the placebo treatment condition as measured by task-based functional magnetic resonance imaging.
Time frame: Week 6, Week 16
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