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Molecular Hydrogen for Cognitive Function and Performance in Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02830854
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : October 28, 2016
Information provided by (Responsible Party):
University of Novi Sad, Faculty of Sport and Physical Education

Brief Summary:
A variety of non-pharmacological interventions have been used in the management of Alzheimer's disease (AD) and similar cognitive disorders in elderly, yet no therapeutic modality has demonstrated conclusive positive results in terms of effectiveness. Although it is still unknown what triggers AD, recent studies have shown that AD is associated with brain energy depletion, oxidative stress, and mitochondrial dysfunction. Since supplemental molecular hydrogen (H2) supports cell energy production and acts as a highly bioavailable mitochondria-related antioxidant, it may provide an ideal agent to facilitate treatment and perhaps prevention of AD and similar cognitive disorders in elderly. The overall hypothesis to be evaluated in this project is that administration of H2 will positively affect patient-reported outcomes and clinical biomarkers in men and women suffering from AD.

Condition or disease Intervention/treatment Phase
Cognitive Impairments Aging Other: Molecular Hydrogen Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : July 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: Molecular Hydrogen
Molecular hydrogen: 20 min per day of 3% H2 during 4 weeks
Other: Molecular Hydrogen

Primary Outcome Measures :
  1. ADAS-Cog score for cognitive function [ Time Frame: Change from Baseline ADAS-Cog Score at 4 weeks ]
    ADAS-Cog total score and scores for 4 separate cognitive domains (memory, orientation, praxis, and language) will be evaluated.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age over 65
  • No psychiatric comorbidities

Exclusion Criteria:

  • Use of dietary supplements 4 weeks before study commence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02830854

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Applied Bioenergetics Lab at Faculty of Sport and PE
Novi Sad, Vojvodina, Serbia, 21000
Sponsors and Collaborators
University of Novi Sad, Faculty of Sport and Physical Education

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Responsible Party: University of Novi Sad, Faculty of Sport and Physical Education Identifier: NCT02830854    
Other Study ID Numbers: DK-DR16-02
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders