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) according to
consensus criteria as defined by Petersen.

4. Clinical Dementia Rating Scale score (CDR) ≤0.5.

5. Adequate vision, hearing, and literacy ability to allow for neuropsychological
testing.

6. Able and willing to perform all study procedures.

7. 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 than
suspected 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 Thyroid-stimulating hormone (TSH) and/or B-12
and/or folic acid levels below the normal range.

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

5. Head trauma or injury immediately preceding cognitive deterioration, unless over 2
years 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 Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria.

9. Concomitant use of medications and/or dietary supplements with potent psychotropic
properties (antipsychotics, ADHD treatments) or approved for the symptomatic
treatment of dementia due to Alzheimer's Disease (AD) or that affect performance,
e.g., NMDA, acetyl choline esterase inhibitors, antipsychotics, alpha-agonists,
adrenergic blockers, decongestant or sympathomimetic, sedating antihistamines, or
lithium carbonate. Usage of prescription or nonprescription antidepressant agents
with a stable dosage for more than 3 month prior study entry is permitted.

10. Concomitant use of dietary supplements containing DHA, EPA, or phosphatidylserine 8
week prior to the study entry and during the study phase. May be re-screened
following wash-out of 8 weeks.

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

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

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