Molecular Hydrogen for Cognitive Function and Performance in Elderly

Aging Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830854
• Other study ID #: DK-DR16-02
• Status: Completed
• Phase: Phase 3
• First received: July 7, 2016
• Last updated: October 27, 2016
• Start date: July 2016
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: University of Novi Sad, Faculty of Sport and Physical Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age over 65

• No psychiatric comorbidities

Exclusion Criteria:

• Use of dietary supplements 4 weeks before study commence

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Aging
• Cognition Disorders
• Cognitive Impairments

Intervention

Other:
• Molecular Hydrogen

Locations

Country	Name	City	State
Serbia	Applied Bioenergetics Lab at Faculty of Sport and PE	Novi Sad	Vojvodina

Sponsors (1)

Lead Sponsor	Collaborator
University of Novi Sad, Faculty of Sport and Physical Education

Country where clinical trial is conducted

Serbia, 

References & Publications (3)

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. Review. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No