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Tests treatment safety and results for Parkinson Disease Psychosis
Official title Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis
ClinicalTrials.gov ID: NCT05824728
What this study is testing
What is AGB101?
AGB101 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for parkinson disease psychosis.
Also referred to as levetiracetam.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join if
- people must meet all of the following at screening:
- people 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.
You likely can't join if
- people must not meet any of the following exclusion criteria at screening:
- 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...
- History of hypersensitivity or lack of side effects 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...
See the full eligibility criteria
Who can join
- people must meet all of the following at screening:
- people 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...
- 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.
- The symptoms of Criterion b are not better accounted for by another cause of Parkinsonism such as dementia with Lewy bodies, psychiatric disorders such as schizophrenia, schizoaffective disorder, delusional disorder, or...
- May have the following associated features:
- With/without insight
- With/without dementia
- With/without treatment for PD
- Patients must be experiencing symptom(s) of Criterion 3b at least once a week during the 4 weeks prior to the screening visit.
- Patients being treated for symptom(s) of Criterion 3b must be off medication for at least 2 weeks prior to randomization.
- Patients must be on a stable regimen of medication for PD for at least 4 weeks prior to randomization.
- Permitted medications:
- With potential pro-cognitive effects, such as cholinesterase inhibitors, memantine, estrogen replacement therapy, must be at a stable dose for 1 month prior to screening and expected to remain stable throughout the study
- Antidepressants must be at a stable dose for 1 month prior to screening and expected to remain stable throughout the study.
- Antipsychotics must be must be at a stable dose for 1 month prior to screening and expected to remain stable throughout the study.
- Willing and able to undergo repeated MRI scans (3 Tesla) with no contraindications to MRI.
- Participant and partner must both be willing to use an effective contraception for duration of the study and for 4 days after it. For women, effective contraception may be hormonal; for men, a condom.
What rules you out
- people must not meet any of the following exclusion criteria at screening:
- 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. people must understand that they may only enroll in this...
- History of hypersensitivity or lack of side effects 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...
- 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...
- 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 how well it works 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 people must not be pregnant or lactating.
- Any other reason, which in the opinion of the investigator would confound proper interpretation of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.