Clinical Trial of AGB101 for Mild Cognitive Impairment

Exclusion Criteria

• •1. Carrying one or more copies of the apolipoprotein E4 (ApoeE4) allele.
• •2. Use of anticonvulsant medications or excluded psychotropic medications within 3 months prior to the baseline visit.
• •3. Use of anti-amyloid medications at any time prior to screening visit, or at any time during the study.
• •4. Participation in a therapeutic clinical study for any medical or psychiatric indications within 3 months (6 months for biologics) 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 3 months (6 months for biologics) prior to screening.
• •5. History of hypersensitivity or lack of tolerability to AGB101 (levetiracetam).
• •6. Severe renal impairment (creatinine clearance of \< 30 mL/minute) or undergoing hemodialysis.
• •7. Any significant neurological disease other than suspected incipient AD, such as Parkinson'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.
• •8. 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.
• •9. Diagnosis of bipolar disorder, or major depression within the past 3 years, as described in the DSM-5. Psychotic features, agitation, or behavioral problems within the last 3 months that could lead to difficulty complying with the protocol. Subjects must not have a major depressive disorder or other types of depression that could confound diagnosis of MCI due to AD, or clinical assessments, in the opinion of the investigator. The Geriatric Depression Scale \[GDS\] (long form score \> 9 suggests depression) results should be reviewed by the investigator to assist in this determination.
• •10. Modified Hachinski Ischemic Scale (HIS) score \> 4.
• •11. History of schizophrenia (DSM-5 criteria).
• •12. History of alcohol or substance abuse or dependence within the past 3 years (DSM-5 criteria).
• •13. Any significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol requirements.
• •14. 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.
• •15. Clinically significant abnormalities in B12 or thyroid function test that might interfere with the study. A low B12 (below normative range for elderly) is exclusionary, unless follow-up labs (homocysteine and methylmalonic acid) indicate that it is not physiologically significant. If the B12 deficiency is treated, subjects may become eligible to participate in the study.
• •16. Residence in a skilled nursing facility. Individuals in independent living communities, assisted living facilities, residential care facilities, or continuing care communities are eligible provided they engage in a sufficient spectrum of activity to permit assessment of all 6 domains contributing to the CDR-SB. Individuals in these facilities must also have a study partner who has the ability to observe the subject during the study and can participate in clinical evaluations.
• •17. Any use of excluded medications (eg, antiepileptics, certain antidepressants or antipsychotics, antihistamines with anticholinergic properties, opiates).
• •18. Participation in clinical studies using the ISLT/BSRT, BPS-O task, or the trail making test (A, B) within 1 month of screening.
• •19. Female subjects must not be pregnant, lactating, or of childbearing potential (ie, they must be 2 years postmenopause or surgically sterile).