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A randomized trial to assess the effects of hydrogen-ride dissolution water for the patients with mild cognitive impairment (MCI).

A randomized trial to assess the effects of hydrogen-ride dissolution water for the patients with mild cognitive impairment (MCI). - An interventional trial for MCI using hydrogen-ride water.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002218
Enrollment
120
Registered
2009-07-17
Start date
2009-07-01
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

mild cognitive impairment

Interventions

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

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Participants of the Tone project. 2) Being able to give a written informed consent to the participation in the present study. 3) Having diagnosis of the mild cognitive impairment. 4) Being able to observe the following requirement: good compliance with the water; participation in the scheduled examinations for assessment; keeping a log-diary recording the consumption of the water. 5) Having a modified Hachinski Ischemic score of 4 or less. 6) 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 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.

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, MRI and SPCET imaging, and 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