Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease

Inclusion Criteria:

1. Subjects between 55 and 85 years old (inclusive) in good general health:

2. Willing and able to consent and participate for the duration of the study

3. Have eighth-grade education or good work history sufficient to exclude mentalretardation

4. Have visual and auditory acuity adequate for neuropsychological testing

5. Have proficient fluency of the native local language to participate in all theneuropsychological test assessments

6. Have a study partner who has sufficient contact with the subject to be able toprovide assessment of memory changes, who can accompany the subject to all theclinic visits for the duration of each visit, and who is able to provide anindependent evaluation of the subject's functioning

7. Have MCI due to AD as defined by all of the following criteria and consistent withthe National Institute on Aging-Alzheimer's Association criteria:

8. MMSE scores between 24 and 30 (inclusive; exceptions may be made for subjectswith <8 years of education at the discretion of the sponsor)

9. A memory complaint reported by the subject or his/her study partner

10. Evidence of lower memory performance based on delayed recall in theInternational Shopping List Test (ISLT)

11. A clinical dementia rating (CDR) score of 0.5 with a memory box score of ≥0.5

12. Essentially preserved activities of daily living

13. Cognitive decline not primarily caused by vascular, traumatic, or medicalproblems (alternative causes of cognitive decline are ruled out)

14. Permitted medications:

15. With potential pro-cognitive effects, such as cholinesterase inhibitors andmemantine, must be at a stable dose for ≥3 months prior to screening and remainstable throughout the study; estrogen replacement therapy, Ginkgo biloba, andvitamin E must be at a stable dose for ≥4 weeks prior to screening and remainstable throughout the study

16. Other psychotropics, such as antidepressants and antipsychotics, must be at astable dose for ≥3 months prior to screening and remain stable throughout thestudy

17. Willing and able to undergo imaging procedures:

18. A Positron Emission Tomography (PET) scan with Florbetaben(an 18F isotopediagnostic agent) or documented evidence of an amyloid positive PET scan.The Florbetaben scan performed at baseline must be read by a qualifiedphysician with experience in reading amyloid PET scans, and it should beconsistent with the presence of amyloid plaques.

19. Repeated MRI scans (3 Tesla) with no contraindications to MRI. MRI scan resultsare consistent with the diagnosis of amnestic MCI due to Alzheimer's diseasewith no clinically significant findings of non-AD pathology that could accountfor the observed cognitive impairment.

20. Willing to allow collection of blood for apolipoprotein E (ApoE) genotyping.

Exclusion Criteria:

1. Use of anticonvulsant medications or excluded psychotropic medications within 3months prior to the baseline visit

2. Participation in a therapeutic clinical study for any medical or psychiatricindications within 3 months (6 months for biologics) of the screening visit, or atany time during the study. Subjects must understand that they may only enroll in this clinical study once; theymay 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, therapeuticdevice, or medical food, in which the last dose/administration was received within 3months (6 months for biologics) prior to screening.

3. History of hypersensitivity or lack of tolerability to AGB101 (levetiracetam)

4. Severe renal impairment (creatinine clearance of <30 mL/minute) or undergoinghemodialysis

5. Any significant neurological disease other than suspected incipient AD, such asParkinson's disease, multi-infarct dementia, Huntington's disease, normal pressurehydrocephalus, 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 persistentneurologic deficits, or known structural brain abnormalities

6. Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metalfragments, or foreign objects in the eyes, skin, or body

7. Diagnosis of major depression or bipolar disorder, as described in the Diagnosticand Statistical Manual of Mental Disorders, 5th Ed (DSM-5), within the past 3 years. Psychotic features, agitation, or behavioral problems within the last 3 months thatcould lead to difficulty complying with the protocol. Subjects must not have a majordepressive disorder or other types of depression that could confound diagnosis ofMCI due to AD, or clinical assessments, in the opinion of the investigator. Thegeriatric depression scale (long form score >9 suggests depression) results shouldbe reviewed by the investigator to assist in this determination.

8. Modified Hachinski Ischemic Scale (HIS) score >4

9. History of schizophrenia (DSM-5 criteria)

10. History of alcohol or substance abuse or dependence within the past 3 years (DSM-5criteria)

11. Any significant systemic illness or unstable medical condition that could lead todifficulty in complying with the protocol requirements.

12. Clinically significant abnormalities in B12 or thyroid function test that mightinterfere 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 physiologicallysignificant. If the B12 deficiency is treated, subjects may become eligible toparticipate in the study.

13. Residence in a skilled nursing facility. Individuals in independent livingcommunities, assisted living facilities, residential care facilities, or continuingcare communities are eligible provided they engage in a sufficient spectrum ofactivity to permit assessment of all 6 domains contributing to the CDR-SB.Individuals in these facilities must also have a caregiver who has the ability toobserve the subject during the study and can participate in clinical evaluations.

14. Any use of excluded medications (e.g., antiepileptics, certain antidepressants orantipsychotics, antihistamines with anticholinergic properties, opiates)

15. Participation in clinical studies using the ISLT, Behavioral Pattern Separation (BPS-O) task, or the trail making test (A, B) within 1 month of screening

16. Female subjects must not be pregnant, lactating, or of childbearing potential (i.e.,they must be 2 years post menopause or surgically sterile)