Back to resultsMolecular Hydrogen for Cognitive Function and Performance in Elderly
Primary Purpose
Cognitive Impairments, Aging
Status
Completed
Phase
Phase 3
Locations
Serbia
Study Type
Interventional
Intervention
Molecular Hydrogen
Sponsored by
About this trial
This is an interventional supportive care trial for Cognitive Impairments
Eligibility Criteria
Inclusion Criteria:
- Age over 65
- No psychiatric comorbidities
Exclusion Criteria:
- Use of dietary supplements 4 weeks before study commence
Sites / Locations
- Applied Bioenergetics Lab at Faculty of Sport and PE
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Molecular Hydrogen
Arm Description
Molecular hydrogen: 20 min per day of 3% H2 during 4 weeks
Outcomes
Primary Outcome Measures
ADAS-Cog score for cognitive function
ADAS-Cog total score and scores for 4 separate cognitive domains (memory, orientation, praxis, and language) will be evaluated.
Secondary Outcome Measures
Full Information
NCT ID
NCT02830854
First Posted
July 7, 2016
Last Updated
October 27, 2016
Sponsor
University of Novi Sad, Faculty of Sport and Physical Education
1. Study Identification
Unique Protocol Identification Number
NCT02830854
Brief Title
Molecular Hydrogen for Cognitive Function and Performance in Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Novi Sad, Faculty of Sport and Physical Education
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairments, Aging
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Molecular Hydrogen
Arm Type
Experimental
Arm Description
Molecular hydrogen: 20 min per day of 3% H2 during 4 weeks
Intervention Type
Other
Intervention Name(s)
Molecular Hydrogen
Primary Outcome Measure Information:
Title
ADAS-Cog score for cognitive function
Description
ADAS-Cog total score and scores for 4 separate cognitive domains (memory, orientation, praxis, and language) will be evaluated.
Time Frame
Change from Baseline ADAS-Cog Score at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age over 65
No psychiatric comorbidities
Exclusion Criteria:
Use of dietary supplements 4 weeks before study commence
Facility Information:
Facility Name
Applied Bioenergetics Lab at Faculty of Sport and PE
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25936365
Citation
Ostojic SM. Molecular hydrogen: An inert gas turns clinically effective. Ann Med. 2015 Jun;47(4):301-4. doi: 10.3109/07853890.2015.1034765. Epub 2015 May 4.
Results Reference
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PubMed Identifier
25720951
Citation
Ostojic SM. Targeting molecular hydrogen to mitochondria: barriers and gateways. Pharmacol Res. 2015 Apr;94:51-3. doi: 10.1016/j.phrs.2015.02.004. Epub 2015 Feb 24.
Results Reference
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PubMed Identifier
22720117
Citation
Ohno K, Ito M, Ichihara M, Ito M. Molecular hydrogen as an emerging therapeutic medical gas for neurodegenerative and other diseases. Oxid Med Cell Longev. 2012;2012:353152. doi: 10.1155/2012/353152. Epub 2012 Jun 8.
Results Reference
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Learn more about this trial
Molecular Hydrogen for Cognitive Function and Performance in Elderly
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