Clinical trial NCT00437983: The Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Age Associated Memory Impairment
Lead sponsor: Enzymotec
Sponsor class: INDUSTRY
First posted: 2007-02-21
Enrollment: 157
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Rey Auditory Verbal Learning Test
timeFrame: baseline, 15 wk
Secondary outcomes:
measure: Blood Work
timeFrame: baseline,15 wk
measure: Trail Making Test
timeFrame: Baseline, 15 weeks
measure: Computerized Cognitive Assessment Tool
timeFrame: baseline, 15 weeks
measure: Clinical Global Impression of Change (CGI-C)Scale
timeFrame: 7 weeks, 15 weeks
measure: Change From Baseline in Rey Osterrieth Complex Figure Test
timeFrame: baseline, 15 weeks
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: The Tel Aviv Sourasky Medical Center, Neurology department
Study officials:
affiliation: Sourasky Medical Center
name: Amos Korczyn, MD
role: STUDY_DIRECTOR
References:
citation: 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.