Memory Impairment
Conditions
Keywords
Age Associated Memory Impairment
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.
Interventions
DIETARY_SUPPLEMENTPhosphatidylserine-Omega3 (SharpPS™-Gold)
Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals. Duration: 15 weeks
Sponsors
Enzymotec
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Neuropsychological Computerized Test | baseline, 15 weeks | The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition & recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression of Change (CGI-C)Scale | 15 weeks | The Clinical Global Impression of Change (CGI-C)scale is designed to record the clinician's global impression of change. Global improvement score ranges from 1 = Very much improved, through 4 = No change, to 7 = Very much worse. Participants who experienced an improvement (scores 1, 2 or 3) were classified as improved over the treatment period. |
Countries
Israel
Participant flow
Recruitment details
Participants were recruited through advertisements in senior citizens' homes, hospitals, and newspapers.
Participants by arm
| Arm | Count |
|---|---|
| PS-Omega3 Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
Baseline characteristics
| Characteristic | PS-Omega3 |
|---|---|
| Age Continuous | 75.29 years STANDARD_DEVIATION 7.09 |
| Region of Enrollment Israel | 18 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Change From Baseline in Neuropsychological Computerized Test
The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition & recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best).
Time frame: baseline, 15 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PS-Omega3 | Change From Baseline in Neuropsychological Computerized Test | Focused Attention | 3.16 Points on a scale | Standard Deviation 12.39 |
| PS-Omega3 | Change From Baseline in Neuropsychological Computerized Test | Sustained Attention | -2.38 Points on a scale | Standard Deviation 11.09 |
| PS-Omega3 | Change From Baseline in Neuropsychological Computerized Test | Memory - Recognition | 1.88 Points on a scale | Standard Deviation 9.86 |
| PS-Omega3 | Change From Baseline in Neuropsychological Computerized Test | Memory - Recall | 4.50 Points on a scale | Standard Deviation 12.14 |
| PS-Omega3 | Change From Baseline in Neuropsychological Computerized Test | VisuoSpatial Learning | 8.83 Points on a scale | Standard Deviation 24.31 |
| PS-Omega3 | Change From Baseline in Neuropsychological Computerized Test | Spatial Short Term Memory | 13.16 Points on a scale | Standard Deviation 29.88 |
| PS-Omega3 | Change From Baseline in Neuropsychological Computerized Test | Executive Functions | -2.88 Points on a scale | Standard Deviation 19.72 |
| PS-Omega3 | Change From Baseline in Neuropsychological Computerized Test | Mental Flexibility | -3.88 Points on a scale | Standard Deviation 20.21 |
Secondary
Clinical Global Impression of Change (CGI-C)Scale
The Clinical Global Impression of Change (CGI-C)scale is designed to record the clinician's global impression of change. Global improvement score ranges from 1 = Very much improved, through 4 = No change, to 7 = Very much worse. Participants who experienced an improvement (scores 1, 2 or 3) were classified as improved over the treatment period.
Time frame: 15 weeks