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

UMIN ID: UMIN000002345

Registered date:18/08/2009

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: mild cognitive impairment
• Date of first enrollment: 2010/08/23
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: Score in Japanese version of ADAS-Cog and Mini Mental State Examination.
• Secondary Outcome: Scores in Japanese version of ADCS-ADL, Geriatric Depression Scale.

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Department of Neuropsychiatry, Institute of Clinical Medicine University of Tsukuba
• Source(s) of Monetary Support: Department of Neuropsychiatry, Institute of Clinical Medicine University of Tsukuba