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A randomised trial to assess the effect of Sea-alpa for the patients with mild cognitive impairment (MCI).

A randomised trial to assess the effect of Sea-alpa for the patients with mild cognitive impairment (MCI). - An interventional trial for MCI using Sea-alpa.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002345
Enrollment
100
Registered
2009-08-18
Start date
2010-08-23
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

mild cognitive impairment

Interventions

The patients of active drug group will be intervened with 6 tablets of Sea-alpa every-day for 1 year. The patients with placebo group will be intervened with 6 tablets of placebo every-day for 1 year.

Sponsors

Department of Neuropsychiatry, Institute of Clinical Medicine University of Tsukuba
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Outpatients with MCI of the department of Neuropsychiatry, University hospital of Tsukuba. 2) Being able to give a written informed consent to the participation in the present study. 3) Being able to observe the following requirements: good compliance with Sea-alpa; participation in the schedules examinations for assessment; keeping log-diary recording consumption of Sea-alpa. 4) Having a modified Hachinski Ischemic score of 4 or less. 5) Having the 15-item Geriatric Depression Scale score of 6 or less.

Exclusion criteria

Exclusion criteria: 1) Meeting DSM-IV TR criteria for dementing illnesses. 2) Having serious or unstable illnesses. 3) Having a history within past 5 years of serious infections disease affecting the brain and/or malignant diseases. 4) Having a history of alcohol or drug abuse or dependence (on DSM-IVTR) within the past 5 years. 5) Receiving any types of anti-Alzheimer drugs. 6) Recent (within 4 weeks) initiation of medications that affect the central nervous system.

Design outcomes

Primary

MeasureTime frame
Score in Japanese version of ADAS-Cog and Mini Mental State Examination.

Secondary

MeasureTime frame
Scores in Japanese version of ADCS-ADL, Geriatric Depression Scale.

Countries

Japan

Contacts

Public ContactTakashi Asada

University of Tsukuba Department of Neuropsychiatry, Institute of Clinical Medicine

tasada@md.tsukuba.ac.jp

Outcome results

None listed

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