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:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT00278135
Eligibility Criteria:
Inclusion Criteria:
* Males or females, aged 55 or greater.
* Have a subjective memory complaint and have a Logical Memory subtest (of the Wechsler Memory Scale - III \[WMS-III\]) raw score one standard deviation or greater below the mean of a younger population.
* Have the ability to understand the requirements of the study; be willing to provide written informed consent; and agree to abide by the study restrictions and return for the required assessments.
* If taking non-prohibited medication, be on a stable drug regimen (in prior 3 months).
Exclusion Criteria:
* Have a screening Mini-Mental State Examination (MMSE) \< 26.
* Consume greater than 200 mg/day DHA as assessed on a DHA Food Frequency Questionnaire in the prior 2 months to screening.
* Use nutritional fish oil, flaxseed oil, omega-3 supplements, or huperzine in the prior 2 months to screening.
* Use acetylcholinesterase inhibitors or memantine in the prior 2 months to screening.
* Use major anti-psychotics or major anti-depressants.
* Use lipase inhibitors such as Xenical® (orlistat).
* History of major medical conditions including ischemic stroke, head trauma with loss of consciousness, epilepsy, psychosis, vascular dementia, depression (Geriatric Depression \[15-item\] \> 5), myocardial infarction (within 1 year), uncontrolled diabetes, or blindness.
* History of major surgery within the past 6 months.
* Current use or history of drug and/or alcohol abuse within 5 years.
* Administration of any investigational product within the past 30 days.
* Inability to swallow capsules.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT00278135
Study Brief:
Protocol Section:
NCT00278135