Molecular Hydrogen for Cognitive Function and Performance in Elderly
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2016
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 7, 2016
CompletedFirst Posted
Study publicly available on registry
July 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedOctober 28, 2016
October 1, 2016
2 months
July 7, 2016
October 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Change from Baseline ADAS-Cog Score at 4 weeks
Study Arms (1)
Molecular Hydrogen
EXPERIMENTALMolecular hydrogen: 20 min per day of 3% H2 during 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Age over 65
- No psychiatric comorbidities
You may not qualify if:
- Use of dietary supplements 4 weeks before study commence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Applied Bioenergetics Lab at Faculty of Sport and PE
Novi Sad, Vojvodina, 21000, Serbia
Related Publications (3)
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.
PMID: 25936365BACKGROUNDOstojic 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.
PMID: 25720951BACKGROUNDOhno 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.
PMID: 22720117BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2016
First Posted
July 13, 2016
Study Start
July 1, 2016
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
October 28, 2016
Record last verified: 2016-10