Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease … (NCT05824728) | Clinical Trial Compass
RecruitingPhase 2
Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis
United States30 participantsStarted 2023-09-28
Plain-language 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.
Who can participate
Age range40 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
What they're measuring
1
Change in hallucinations/delusions as assessed by the Enhanced Scale for Assessment of Positive Symptoms in Parkinson's Disease (eSAPS-PD)
✕. 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.
✕. 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.
✕. 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.