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

NCT00437983 | Completed Phase 4 Results

• 1 other identifier: Memory_PS 001
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Age Associated Memory Impairment

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Rey Auditory Verbal Learning Test

  A widely used, brief, easy to understand scale to evaluate verbal learning and memory. The score is presented as the number of words correctly recalled (0 is worse, 15 is best).The total learning task score ranges from 0 to 45 words(0 is worse, 45 is best).

  baseline, 15 wk

Secondary Outcomes (5)

• Blood Work

  baseline,15 wk

• Trail Making Test

  Baseline, 15 weeks

• Computerized Cognitive Assessment Tool

  baseline, 15 weeks

• Clinical Global Impression of Change (CGI-C)Scale

  7 weeks, 15 weeks

• Change From Baseline in Rey Osterrieth Complex Figure Test

  baseline, 15 weeks

Study Arms (2)

PS-Omega3

ACTIVE COMPARATOR

Phosphatidylserine-Omega3, 300mg/day 15 wk

Dietary Supplement: PS-Omega3

Placebo

PLACEBO COMPARATOR

Cellulose tainted with fishy odor, 3 capsules/day

Dietary Supplement: Placebo

Interventions

PS-Omega3 DIETARY_SUPPLEMENT

Phosphatidylserine-Omega3 capsules 3x100mg/day 15 wk. Next, follow up phase, open label,1x100mg/day, 15 wk

PS-Omega3

Placebo DIETARY_SUPPLEMENT

Placebo cellulose tainted with fishy odor capsules 3x100mg/day 15 wk

Placebo

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to give written informed consent
• Age: 90≥ years ≥50
• Gender: male and female
• CDR ≤ 0.5
• 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.
• Mini-Mental State Examination (MMSE) ≥27 for subjects with college education (BA) and ≥ 26 for all others
• Memory test performance that is at least 1 SD below the mean established for young adults on at least one neuropsychological subtest of NexAde.
• Language: Subjects must be able to read, write and speak Hebrew.
• Ability to perform tests and interviews

You may not qualify if:

• Evidence of delirium, confusion, or other disturbances of consciousness
• 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
• History of any infective or inflammatory brain disease including those of viral, fungal, or syphilitic etiologies
• Evidence of significant cerebral vascular pathology
• Head injury immediately preceding cognitive deterioration.
• Current psychiatric diagnosis according to DSM IV criteria of depression, mania, or any other major psychiatric disorder
• Current diagnosis or history of alcoholism or drug dependence.
• Evidence of depression as determined by the Geriatric Depression Scale (short version) score of 5 or more.
• 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
• Use of psychotropic drug or any other drug or supplement that may significantly affect cognitive functioning during the month prior to psychometric testing.
• Use of any experimental medication within 1 month prior to screening or as concomitant medications.
• Subject has a history of hypersensitivity or allergy to fish or fish oil or soy.

Sponsors & Collaborators

• Enzymotec: lead

Study Sites (1)

The Tel Aviv Sourasky Medical Center, Neurology department

Tel Aviv, 64239, Israel

Location

Related Publications (1)

• Vakhapova V, Richter Y, Cohen T, Herzog Y, Korczyn AD. Safety of phosphatidylserine containing omega-3 fatty acids in non-demented elderly: a double-blind placebo-controlled trial followed by an open-label extension. BMC Neurol. 2011 Jun 28;11:79. doi: 10.1186/1471-2377-11-79.

  PMID: 21711517 DERIVED

Results Point of Contact

• Title: Prof. A. Korczyn
• Organization: Sourazky Tel-Aviv Medical Center

amosk@tasmc.health.gov.il

972-3-6974229

Study Officials

• Amos Korczyn, MD

  Sourasky Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 20, 2007
• First Posted: February 21, 2007
• Study Start: April 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 5, 2010
• Results First Posted: November 25, 2009

Record last verified: 2010-01

Locations

IL (1)