Age Associated Memory Impairment
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPS-Omega3
Phosphatidylserine-Omega3 capsules 3x100mg/day 15 wk. Next, follow up phase, open label,1x100mg/day, 15 wk
DIETARY_SUPPLEMENTPlacebo
Placebo cellulose tainted with fishy odor capsules 3x100mg/day 15 wk
Sponsors
Enzymotec
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Rey Auditory Verbal Learning Test | baseline, 15 wk | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) in at least one of the two visits (following 7 or 15 weeks of treatment) were classified as improved over the treatment period (with the exception of participants reporting improvement following 7 weeks and deterioration at endpoint, who were NOT rated as improved) |
| Change From Baseline in Rey Osterrieth Complex Figure Test | baseline, 15 weeks | A widely used neuropsychological tool for the evaluation of visuospatial constructional ability and visual memory. Both the time to complete the task (copy time)and the accuracy (immediate and delayed recall) were used as measures for the analysis. Accuracy range score is 0-36 points (0 is worse, 36 is best). Copy time is expressed in seconds (less time to copy indicates better performance). |
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 Phosphatidylserine-Omega3, 300mg/day 15 wk | 79 |
| Placebo Cellulose tainted with fishy odor | 78 |
| Total | 157 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 6 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 6 |
Baseline characteristics
| Characteristic | PS-Omega3 | Placebo | Total |
|---|---|---|---|
| Age Continuous | 72.58 years STANDARD_DEVIATION 8.12 | 72.46 years STANDARD_DEVIATION 8.33 | 72.52 years STANDARD_DEVIATION 8.2 |
| Region of Enrollment Israel | 79 participants | 78 participants | 157 participants |
| Sex: Female, Male Female | 39 Participants | 39 Participants | 78 Participants |
| Sex: Female, Male Male | 40 Participants | 39 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 79 | 0 / 78 |
| serious Total, serious adverse events | 0 / 79 | 0 / 78 |
Outcome results
Primary
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).
Time frame: baseline, 15 wk
Population: Analysis of per-protocol (PP) cohort. Out of the 131 participants who completed the study, nine were excluded from the PP analysis (5 from the placebo group and 4 from the PS-omega3 group), one due to short interval between visits and the rest didn't meet the compliance criteria (≥ 65%).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PS-Omega3 | Change From Baseline in Rey Auditory Verbal Learning Test | Immediate recall | 1.53 number of words correctly recalled | Standard Error 0.26 |
| PS-Omega3 | Change From Baseline in Rey Auditory Verbal Learning Test | Total Learning | 5.30 number of words correctly recalled | Standard Error 0.89 |
| PS-Omega3 | Change From Baseline in Rey Auditory Verbal Learning Test | Delayed recall | 0.93 number of words correctly recalled | Standard Error 0.29 |
| Placebo | Change From Baseline in Rey Auditory Verbal Learning Test | Immediate recall | 1.00 number of words correctly recalled | Standard Error 0.2 |
| Placebo | Change From Baseline in Rey Auditory Verbal Learning Test | Total Learning | 4.02 number of words correctly recalled | Standard Error 0.85 |
| Placebo | Change From Baseline in Rey Auditory Verbal Learning Test | Delayed recall | 0.79 number of words correctly recalled | Standard Error 0.35 |
Secondary
Blood Work
Time frame: baseline,15 wk
Secondary
Change From Baseline in Rey Osterrieth Complex Figure Test
A widely used neuropsychological tool for the evaluation of visuospatial constructional ability and visual memory. Both the time to complete the task (copy time)and the accuracy (immediate and delayed recall) were used as measures for the analysis. Accuracy range score is 0-36 points (0 is worse, 36 is best). Copy time is expressed in seconds (less time to copy indicates better performance).
Time frame: baseline, 15 weeks
Population: Analysis of per-protocol (PP) cohort. Out of the 131 participants who completed the study, nine were excluded from the PP analysis (5 from the placebo group and 4 from the PS-omega3 group), one due to short interval between visits and the rest didn't meet the compliance criteria (≥ 65%).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PS-Omega3 | Change From Baseline in Rey Osterrieth Complex Figure Test | Copy Time (sec) | -23.27 Units on a scale | Standard Error 8.92 |
| PS-Omega3 | Change From Baseline in Rey Osterrieth Complex Figure Test | Immediate recall | 2.73 Units on a scale | Standard Error 0.68 |
| PS-Omega3 | Change From Baseline in Rey Osterrieth Complex Figure Test | Delayed recall | 2.28 Units on a scale | Standard Error 0.68 |
| Placebo | Change From Baseline in Rey Osterrieth Complex Figure Test | Copy Time (sec) | 3.73 Units on a scale | Standard Error 12.44 |
| Placebo | Change From Baseline in Rey Osterrieth Complex Figure Test | Immediate recall | 1.35 Units on a scale | Standard Error 0.66 |
| Placebo | Change From Baseline in Rey Osterrieth Complex Figure Test | Delayed recall | 2.37 Units on a scale | Standard Error 0.67 |
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) in at least one of the two visits (following 7 or 15 weeks of treatment) were classified as improved over the treatment period (with the exception of participants reporting improvement following 7 weeks and deterioration at endpoint, who were NOT rated as improved)
Time frame: 7 weeks, 15 weeks
Population: Analysis of per-protocol (PP) cohort. Out of the 131 participants who completed the study, nine were excluded from the PP analysis (5 from the placebo group and 4 from the PS-omega3 group), one due to short interval between visits and the rest didn't meet the compliance criteria (≥ 65%).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PS-Omega3 | Clinical Global Impression of Change (CGI-C)Scale | 22 Participants who experienced improvement |
| Placebo | Clinical Global Impression of Change (CGI-C)Scale | 17 Participants who experienced improvement |
Secondary
Computerized Cognitive Assessment Tool
Time frame: baseline, 15 weeks
Secondary
Trail Making Test
Time frame: Baseline, 15 weeks