Elderly, Memory Impairment
Conditions
Keywords
Cognitex, subjects
Brief summary
A Single-Center, Open Label Study to Assess the Efficacy of Cognitex in Elderly Subjects with Memory Impairment
Interventions
DIETARY_SUPPLEMENTCognitex
Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
Sponsors
Enzymotec
Tel-Aviv Sourasky Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
1. Ability to give written informed consent. 2. Age: 90≥ years ≥60. 3. Gender: male and female. 4. Memory test performance within or below the mean established for adults in the computerized cognitive tool, with a maximum of four neuropsychological subtests scored 1.5 SD above the mean. 5. Language: Subjects must be able to read, write and speak Hebrew. 6. Ability to perform tests and interviews.
Exclusion criteria
1. Evidence of delirium, confusion, or other disturbances of consciousness. 2. Evidence of dementia. 3. Any Neurological disorder that could produce cognitive deterioration. Such disorders include Parkinson's disease, stroke, intracranial hemorrhage, local brain lesions including tumors and normal pressure hydrocephalus. 4. History of any infective or inflammatory brain disease including those of viral, fungal, or syphilitic etiologies. 5. Head injury immediately preceding cognitive deterioration. 6. Evidence of depression as determined by a the Geriatric Depression Scale (short version) score of 5 or more. 7. Current diagnosis or history of alcoholism or drug dependence. 8. 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 9. Use of anti-clotting or antiplatelet medications or supplements for less than two years. 10. History of clotting or platelet disorder unless well controlled. 11. Use of any supplement that may significantly affect cognitive functioning during the month prior to study initiation. 12. Use of any experimental medication within 1 month prior to screening or as concomitant medications. 13. History of hypersensitivity or allergy to soy or fish.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test) | Base line and 12 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). |
Countries
Israel
Participant flow
Recruitment details
Participants were recruited through advertisements in senior citizens' homes, hospitals, and newspapers.
Participants by arm
| Arm | Count |
|---|---|
| Cognitex Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
Baseline characteristics
| Characteristic | Cognitex |
|---|---|
| Age Continuous | 72.97 years STANDARD_DEVIATION 6.16 |
| Region of Enrollment Israel | 30 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Improvement of Cognitive Performance (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: Base line and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitex | Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test) | Focused Attention | 3.46 Points on a scale | Standard Error 1.72 |
| Cognitex | Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test) | Sustained Attention | 13.19 Points on a scale | Standard Error 3.02 |
| Cognitex | Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test) | Memory - Recognition | 7.92 Points on a scale | Standard Error 2.13 |
| Cognitex | Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test) | Memory - Recall | 9.19 Points on a scale | Standard Error 2.44 |
| Cognitex | Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test) | VisuoSpatial Learning | 19.84 Points on a scale | Standard Error 3.78 |
| Cognitex | Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test) | Spatial Short Term Memory | 18.88 Points on a scale | Standard Error 4.62 |
| Cognitex | Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test) | Executive Functions | 18.61 Points on a scale | Standard Error 3.79 |
| Cognitex | Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test) | Mental Flexibility | 19.65 Points on a scale | Standard Error 3.8 |