A Double-Blind, Placebo-Controlled Study With 2-Docosahexaenoyl-3-Phosphatidylserine in Cognitive Disorder
- Conditions
- Cognitive Disorder
- Registration Number
- JPRN-UMIN000002575
- Lead Sponsor
- Polyene Project, Ltd.
- Brief Summary
There was no statistically significant difference between groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
1. Those aged between 55 and 64 whose scores of MMSE are under 21, those aged between 65 or over whose scores are under 18. 2. Those who, during the last 3 months, have continuously been taking central nervous system agent(s). However, those who have continuously been taking them at low dose levels as sleep-inducers are eligible. 3. Those who, during the last three months, have continuously been taking supplement(s) as follows: fish oils, phosphatidylserine, phosphatidylcholine or any other supplements which affect lipid metabolism. 4. Those suffering from alcoholism, schizophrenia, bipolar disorder or other psychiatric disorders. 5. Those suffering from other serious organic disease such as cancer. 6. Those who are allergic to marine products including cuttlefishes or octopuses. 7. Those who are considered not to be appropriate for the study by the doctor in charge of the present trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [Time Frame: 0, 12 weeks]
- Secondary Outcome Measures
Name Time Method Profile of Mood States (POMS) [Time Frame: 0, 6,12 weeks] Japanese Adult Reading Test (JART) [Time Frame: 0 week] Brain CT or MRI [Time Frame: 0 week] Serum Brain-Derived Neurotrophic Factor(BDNF) [Time Frame: 0, 12 weeks] Food frequency questionnaire [Time Frame: 0 week]