Investigating a Phosphatidylserine Based Dietary Approach for the Management of Mild Cognitive Impairment

Inclusion Criteria:

1. Age greater than or equal to 65 and less than or equal to 85 years.

2. Formal education greater than or equal to 10 years.

3. Male or female with a diagnosis of Mild Cognitive Impairment (MCI) 3. Male or femalewith a diagnosis of Mild Cognitive Impairment (MCI) as defined by Peterson, accordingto The following:

3.1 Clinical Dementia Rating Scale total score (CDR) ≤0.5, and score of each one ofthe six categories ("box scores") ≤ 1. 3.2 Mini Mental State Exam > 24 3.3 VerbalPaired-Associated Learning test score according to the following ages: Ages 65-70 lessthan or equal to 18 Ages 71-85* less than or equal to 17

*Eligibility of subjects aged between 70 and 71 (i.e., 70.1) will be evaluatedaccording to 71-85 age group score.

4. Adequate vision, hearing, and literacy ability to allow for neuropsychologicaltesting.

5. Able and willing to perform all study procedures.

6. Ability to provide written consent signed by the subject

Exclusion Criteria:

1. Any significant neurological condition or disorder (e.g., seizure disorder, epilepsy,brain tumors, stroke, etc.) that could cause cognitive deterioration other thansuspected MCI.

2. Any medical condition or disorder that could produce cognitive deterioration (i.e.,renal, respiratory, cardiac, and hepatic disease, diabetes mellitus, endocrine,metabolic or hematological disturbances) unless well controlled for at least 3 months.

3. Clinically significant abnormal serum TSH and/or B-12 and/or folic acid levels belowthe normal range.

4. History of any infective or inflammatory brain disease including viral, fungal orsyphilitic etiologies.

5. Head trauma or injury immediately preceding cognitive deterioration, unless over 2years have passed since full cognitive and functional recovery.

6. Depression at screening as assessed by Geriatric Depression Scale-short version (score ≥5)

7. Current suicidality at screening by Columbia Suicidality Severity Rating Scale.

8. Dementia by DSM-IV criteria.

9. Concomitant use of medications with potent psychotropic properties (e.g.antipsychotics, ADHD treatments, lithium carbonate, anti-epileptic drugs such asGabapentin). Sedating antihistamines are allowed if administered last dose isadministered at least 12 hours before cognitive testing. Usage of prescription ornonprescription antidepressant agents, lipid lowering medications, andanti-hypertensive medications with a stable dosage for more than 2 months prior studyentry is permitted.

10. Concomitant use of any medications approved for the symptomatic treatment of dementiadue to AD (e.g., NMDA, acetyl choline esterase inhibitors)

11. Use within 3 weeks prior to study entry of any medications with any anti-cholinergiceffect (e.g. Atropine, Scopolamine, Tolterodine, Hyoscyamine, Biperiden, Benzatropine,Trihexyphenidyl, Oxybutynin).

12. Use within 4 weeks prior to the study entry of dietary supplements containing DHA,EPA, Phosphatidylserine, Phosphatidylcholine (e.g. Krill oil, Lecithin), oralpha-glycerphosphocholine (GPC).

13. Use within 4 weeks prior to the study entry of medical foods indicated for cognitiveor memory impairment [e.g. Axona, Cerefolin, CerefolinNAC, Souvenaid].

14. Concomitant use of any supplements containing ingredients with nootropic orvasodilator properties (e.g., Ginkgo Biloba, Vinpocetine, Piracetam, high energysupplements).

15. Use of an investigational drug within the last 30 days.

16. Allergic reaction or sensitivity to marine products (fish/seafood) and/or soy.

17. Any known condition which in the opinion of the investigator may be possibly causingcognitive impairment other than AD (mania, alcohol or substance abuse, mentalretardation, bipolar disorder, panic disorder, obsessive compulsive disorder,post-traumatic stress disorder, psychotic disorder, major psychiatric disorderpreceding dementia onset or affecting brain function, major surgery ) and/or limitsthe successful trial completion