The Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment

Enzymotec

Status and phase: Completed; Phase 4

Conditions: Age Associated Memory Impairment

Treatments: Dietary Supplement: Placebo; Dietary Supplement: PS-Omega3

Study type: Interventional

Funder types: Industry

Identifiers

NCT00437983

Memory_PS 001

Details and patient eligibility

About

The primary objective of this trial is to assess the ability of an oral administration of Phosphatidylserine-Omega3 to improve attention and memory complaints in comparison to placebo in age associated memory impaired subjects.

Enrollment: 157 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Ability to give written informed consent
2. Age: 90≥ years ≥50
3. Gender: male and female
4. CDR ≤ 0.5
5. Complaints of memory loss reflected in such everyday problems as difficulty remembering names of individuals following introduction, misplacing objects, difficulty remembering multiple items to be purchased or multiple tasks to be performed, difficulty remembering telephone numbers or zip codes, and difficulty recalling information quickly or following distraction. Onset of memory loss must be described as gradual, without sudden worsening in recent months. Complaints of memory loss to be assessed by the MAC-Q scale.
6. Mini-Mental State Examination (MMSE) ≥27 for subjects with college education (BA) and ≥ 26 for all others
7. Memory test performance that is at least 1 SD below the mean established for young adults on at least one neuropsychological subtest of NexAde.
8. Language: Subjects must be able to read, write and speak Hebrew.
9. Ability to perform tests and interviews

Exclusion criteria

1. Evidence of delirium, confusion, or other disturbances of consciousness
2. Any Neurological disorder that could produce cognitive deterioration. Such disorders include AD, Parkinson's disease, stroke, intracranial hemorrhage, local brain lesions including tumors, and normal pressure hydrocephalus
3. History of any infective or inflammatory brain disease including those of viral, fungal, or syphilitic etiologies
4. Evidence of significant cerebral vascular pathology
5. Head injury immediately preceding cognitive deterioration.
6. Current psychiatric diagnosis according to DSM IV criteria of depression, mania, or any other major psychiatric disorder
7. Current diagnosis or history of alcoholism or drug dependence.
8. Evidence of depression as determined by the Geriatric Depression Scale (short version) score of 5 or more.
9. Any medical disorder that could produce cognitive deterioration including renal, respiratory, cardiac, and hepatic disease, diabetes mellitus, endocrine, metabolic or hematological disturbances unless well controlled, and malignancy not in remission for more than two years
10. Use of psychotropic drug or any other drug or supplement that may significantly affect cognitive functioning during the month prior to psychometric testing.
11. Use of any experimental medication within 1 month prior to screening or as concomitant medications.
12. Subject has a history of hypersensitivity or allergy to fish or fish oil or soy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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157 participants in 2 patient groups, including a placebo group

PS-Omega3

Active Comparator group

Description:

Phosphatidylserine-Omega3, 300mg/day 15 wk

Treatment:

Dietary Supplement: PS-Omega3

Placebo

Placebo Comparator group

Description:

Cellulose tainted with fishy odor, 3 capsules/day

Treatment:

Dietary Supplement: Placebo