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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00437983
Other study ID # Memory_PS 001
Secondary ID
Status Completed
Phase Phase 4
First received February 20, 2007
Last updated January 3, 2010
Start date April 2007
Est. completion date September 2008

Study information

Verified date January 2010
Source Enzymotec
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 157
Est. completion date September 2008
Est. primary completion date June 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years to 90 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
PS-Omega3
Phosphatidylserine-Omega3 capsules 3x100mg/day 15 wk. Next, follow up phase, open label,1x100mg/day, 15 wk
Placebo
Placebo cellulose tainted with fishy odor capsules 3x100mg/day 15 wk

Locations

Country Name City State
Israel The Tel Aviv Sourasky Medical Center, Neurology department Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Enzymotec

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Rey Auditory Verbal Learning Test baseline, 15 wk No
Secondary Blood Work baseline,15 wk Yes
Secondary Trail Making Test Baseline, 15 weeks No
Secondary Computerized Cognitive Assessment Tool baseline, 15 weeks No
Secondary Clinical Global Impression of Change (CGI-C)Scale 7 weeks, 15 weeks No
Secondary Change From Baseline in Rey Osterrieth Complex Figure Test baseline, 15 weeks No