Molecular Hydrogen for Cognitive Function and Performance in Elderly

October 27, 2016 updated by: University of Novi Sad, Faculty of Sport and Physical Education
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Applied Bioenergetics Lab at Faculty of Sport and PE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age over 65
  • No psychiatric comorbidities

Exclusion Criteria:

  • Use of dietary supplements 4 weeks before study commence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline ADAS-Cog Score at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

July 7, 2016

First Submitted That Met QC Criteria

July 8, 2016

First Posted (Estimate)

July 13, 2016

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK-DR16-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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