Study of the Pharmacokinetics and Pharmacodynamics of POSIPHEN® in Subjects With Amnestic Mild Cognitive Impairment

Inclusion Criteria

• •1. Males or post-menopausal females aged 55 to 80 years, inclusive.
• •2. Must have Mild Cognitive Impairment (MCI) (amnestic subtype) according to Petersen's criteria (2004).
• •3. Mini Mental Status Examination (MMSE) score should be ≥24.
• •4. Must score below a pre-determined cut-off score on the logical memory II delayed paragraph recall sub-test of the Wechsler Memory Scale Revised (WMS-R).
• •5. Must have a Clinical Dementia Rating of 0.5 with a memory box score of 0.5 or 1.0.
• •6. Modified Hachinski score of less than or equal to 4.
• •7. Hamilton Depression rating scale (HAMD17) score of less than or equal to 12 with a score of 0 on items 1, 2, and 3 (depressed mood, feelings of guilt, and suicidal ideation).
• •8. No evidence of current suicidal ideation or previous suicide attempt in past 2 years as evaluated in the Columbia Suicidality Checklist.
• •9. MRI scans within 12 months prior to screening, or per screening MRI, without evidence of infection, infarction, or other focal lesions and without clinical symptoms suggestive of intervening neurological disease.
• •10. No clinically significant abnormalities in the lumbar spine should be present on a lumbar X-ray that would contraindicate lumbar puncture.
• •11. Adequate visual and hearing ability (physical ability to perform all the study assessments).
• •12. Normal B12, folic acid, and thyroid function tests (thyroid stimulating hormone \[TSH\], free T4, and free T3).
• •13. Do not require nursing home care.