Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT00736034
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
90 Years
Study:
NCT00736034
Study Brief:
Protocol Section:
NCT00736034