A Double-Blind, Placebo-Controlled Study With 2-Docosahexaenoyl-3-Phosphatidylserine in Cognitive Disorder

A Double-Blind, Placebo-Controlled Study With 2-Docosahexaenoyl-3-Phosphatidylserine in Cognitive Disorder - A Double-Blind, Placebo-Controlled Study With 2-Docosahexaenoyl-3-Phosphatidylserine in Cognitive Disorder

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002575

Enrollment

Registered

2009-10-05

Start date

2009-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Disorder

Interventions

2-Docosahexaenoyl-3-Phosphatidylserine 100 mg/day (9 capsules/day) for 12 weeks 2-Docosahexaenoyl-3-Phosphatidylserine 300 mg/day (9 capsules/day) for 12 weeks Placebo (9 capsules/day) for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Those who are 55 years old or older without any physical impairment in daily life. 2. Those who have subjective memory impairment 3. Those aged between 55 and 59 whose total scores of RBANS are 220 or under, those aged between 60 and 69 whose scores are 200 or under, and those aged 70 or over whose scores are 180 or under.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [Time Frame: 0, 12 weeks]	—

Secondary

Measure	Time frame
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]	—

Countries

Japan

Contacts

Public ContactKei Hamazaki

Polyene Project, Ltd. Dept of Clinical Science

keihama@med.u-toyama.ac.jp076-434-7617

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026