Molecular Hydrogen for Cognitive Function and Performance in Elderly

Sponsor

University of Novi Sad, Faculty of Sport and Physical Education (Other)

Overall Status

Completed

CT.gov ID

NCT02830854

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Molecular Hydrogen

Molecular hydrogen: 20 min per day of 3% H2 during 4 weeks

Other: Molecular Hydrogen

Outcome Measures

Primary Outcome Measures

ADAS-Cog score for cognitive function [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of Novi Sad, Faculty of Sport and Physical Education

ClinicalTrials.gov Identifier:

NCT02830854

Other Study ID Numbers:

DK-DR16-02

First Posted:

Jul 13, 2016

Last Update Posted:

Oct 28, 2016

Last Verified:

Oct 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Cognitive Dysfunction

Study Results

No Results Posted as of Oct 28, 2016