Clinical trial NCT00736034: The Efficacy of Phosphatidylserine-Omega3 in Elderly Subjects With Memory Impairment
Official title: A Single-Center, Open-Label Study to Assess the Efficacy of SharpPS™-Gold in Elderly Subjects With Memory Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Memory Impairment
Keywords: Age Associated Memory Impairment
Lead sponsor: Enzymotec
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 18
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to assess the ability of Phosphatidylserine-Omega3 to improve cognitive performance in elderly subjects with memory impairment.

This study is a single-center, open-label 15 weeks duration trial to assess efficacy of Phosphatidylserine-Omega3 in elderly subjects with memory impairment.


Eligibility criteria: INCLUSION CRITERIA

1. Ability to give written informed consent
2. Age: 90≥ years ≥65
3. Gender: male and female.
4. Clinical Dementia Rating Scale (CDR) ≤ 0.5
5. Mini-Mental State Examination (MMSE) ≥ 26
6. Memory test performance within or below the mean established for adults, with maximum of four neuropsychological subtests of the computerized test scored as 1.5 SD above the mean
7. Language: Subjects must be able to read, write and speak Hebrew.
8. 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. Head injury immediately preceding cognitive deterioration.
5. Current psychiatric diagnosis according to DSM IV criteria of depression, mania, or any other major psychiatric disorder, or evidence of depression as determined by the Geriatric Depression Scale (GDS15) score of 5 or more.
6. Current diagnosis or history of alcoholism or drug dependence.
7. 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.
8. Use of psychotropic drug or any other drug or supplement that may significantly affect cognitive functioning during the month prior to psychometric testing.
9. Use of any experimental medication within 1 month prior to screening or as concomitant medications.
10. History of hypersensitivity or allergy to fish or fish oil.

Primary outcomes:
measure: Change From Baseline in Neuropsychological Computerized Test
timeFrame: baseline, 15 weeks
Secondary outcomes:
measure: Clinical Global Impression of Change (CGI-C)Scale
timeFrame: 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: Veronica Vakhapova, MD
role: PRINCIPAL_INVESTIGATOR
References: