UMIN ID: UMIN000002218
Registered date:17/07/2009
A randomized trial to assess the effects of hydrogen-ride dissolution water for the patients with mild cognitive impairment (MCI).
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | mild cognitive impairment |
Date of first enrollment | 2009/07/01 |
Target sample size | 120 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | The patients of hydrogen group will be intervened with 500ml hydrogen dissolution water every-day for 2 years. The patients of placebo group will be intervened with 500ml ordinary water every-day for 2 years. |
Outcome(s)
Primary Outcome | Score in Japanese version of ADAS-Cog and Mini Mental State Examination. |
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Secondary Outcome | Scores in Japanese version of ADCS-ADL, MRI and SPCET imaging, and Geriatric Depression Scale. |
Key inclusion & exclusion criteria
Age minimum | 67years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
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 infectious disease affecting the brain and/or malignant diseases. 4) Having a history of alcohol or drug abuse or dependence (on DSM-IV TR) 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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | Department of Neuropsychiatry, Institute of Clinical Medicine University of Tsukuba |
Secondary ID(s) |
Contact
public contact | |
Name | Takashi Asada |
Address | 1-1-1, Tennodai, Tsukuba City, Ibaraki-prefecture Japan |
Telephone | |
tasada@md.tsukuba.ac.jp | |
Affiliation | University of Tsukuba Department of Neuropsychiatry, Institute of Clinical Medicine |
scientific contact | |
Name | Takashi Asada |
Address | 1-1-1, Tennodai, Tsukuba City, Ibaraki-prefecture, Japan |
Telephone | +81(29)853-3178 |
Affiliation | University of Tsukuba Department of Neuropsychiatry, Institute of Clinical Medicine |