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The verification study for neurocognitive status improvement: A randomized double-blind placebo-controlled trial

The verification study for neurocognitive status improvement: A randomized double-blind placebo-controlled trial - The verification study for neurocognitive status improvement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026297
Enrollment
60
Registered
2017-02-24
Start date
2017-02-27
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

Healthy adults

Interventions

Duration: 12 weeks Test materials: Sea squirt-derived plasmalogen capsule Dose: 1 capsule, once a day Administration: Take 1 capsule per day any time during the day Duration: 12 weeks Test mater

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Seishin-kai Medical Association Inc, Takara Medical Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese adults who feel memory loss 2. Those who are not dementia and are considered as appropriate for the study by the physician 3. Those who get 24 or more in score of MMSE 4. Those who have lower score in total score of Cognitrax

Exclusion criteria

Exclusion criteria: 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Those who have dementia 4. Those who have depression disorder, ADHD, or etc. such as mental illness 5. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 6. Currently taking medicines and/or herbal medicines 7. Those who take DHA or/and EPA-containing food in daily 8. Those who are allergic to medicines and/or the test food related products 9. Those who are pregnant, breast-feeding, and plan to become a pregnant 10. Those who had participated another clinical test for three months when you signed the informed consent form for this trial 11. Others considered as inappropriate for the study by the physician

Design outcomes

Primary

MeasureTime frame
1. Neuropsychological tests (Cognitrax)

Secondary

MeasureTime frame
1. Dementia Assessment Sheet in Community-based Integrated Care System (DASC-21) 2. Original questionnaire (Likert scale)

Countries

Japan

Contacts

Public ContactNaoko SUZUKI

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

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