Clinical Trial Evaluating the Efficacy of AGB101 for Reducing Hippocampal Overactivity in Older Adults

Subjects must meet all of the following inclusion criteria at screening:

1. Subjects between 50 and 80 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 (≥ 2 hours per week) with thesubject and can provide assessments of any changes and an independent evaluation ofthe subject's functioning.

7. Have normal cognition as defined by the following criteria:

8. Mini-Mental State Examination (MMSE) scores between 27 and 30 (inclusive;exceptions may be made for subjects with < 12 years of education at thediscretion of the investigator)

9. No memory complaint reported by the subject or his/her study partner.

10. Evidence of normal memory function documented by a normal score on the BuschkeSelective Reminding Test Immediate and Delayed Recall or equivalent test.

11. A Clinical Dementia Rating Scale (CDR) global score of 0 with a memory boxscore of 0.

12. Antidepressants must be at a stable dose for 1 month prior to screening and expectedto remain stable throughout the study.

13. Willing and able to undergo repeated MRI scans (3 Tesla) with no contraindicationsto MRI.

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

15. Willing and able to undergo a Tau positron emission tomography (PET) scan with 18FMK-6240 tracer.

16. If female participant or partner/spouse is of childbearing age, participant and/orpartner must be willing to use an effective contraception for duration of the studyand for 4 days after it. For women, effective contraception may be hormonal; formen, a condom.

Exclusion Criteria:

• Subjects must not meet any of the following exclusion criteria at screening:

1. Use of anticonvulsant or anticoagulant medications within 1 month prior to thebaseline visit.

2. Participation in a therapeutic clinical study for any medical or psychiatricindications within 1 month of the screening visit, or at any time during thestudy. Subjects must understand that participants may only enroll in thisclinical study once; participants may not enroll in any other clinical studywhile participating in the current study, and participants may not participatein a clinical study of a drug, biologic, therapeutic device, or medical food,in which the last dose/administration was received within 1 month prior toscreening.

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 such as Parkinson's disease, Alzheimer'sdisease, multi-infarct dementia, Huntington's disease, normal pressurehydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder (lifetime history; infant febrile seizures are not exclusionary), subduralhematoma, multiple sclerosis, or history of significant head trauma followed bypersistent neurologic deficits, or known structural brain abnormalities, thatin the opinion of the investigator might interfere with the conduct of thestudy.

6. Diagnosis of major depression within the last 3 years or prior diagnosis ofschizophrenia, bipolar disorder or other psychotic disorder.

7. Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants,metal fragments, or foreign objects in the eyes, skin, or body that constitutea contraindication to having an MRI scan.

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

9. Any significant systemic illness or unstable medical condition that could leadto difficulty in complying with the protocol requirements.

10. Any unstable medical condition that is likely to require new medical orsurgical treatment during the course of the study and where such treatmentsmight affect the collection of efficacy data.

11. Current suicidal ideation.

12. Female subjects must not be pregnant or lactating.

13. Any other reason, which in the opinion of the investigator would confoundproper interpretation of the study.