Molecular Hydrogen for Cognitive Function and Performance in Elderly

Phase 3

Completed

• Conditions: Cognitive Impairments; Aging
• Interventions: Other: Molecular Hydrogen

• Registration Number: NCT02830854
• Lead Sponsor: University of Novi Sad, Faculty of Sport and Physical Education

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-07
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-13
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Age over 65
• No psychiatric comorbidities

Exclusion Criteria

• Use of dietary supplements 4 weeks before study commence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Molecular Hydrogen	Molecular Hydrogen	Molecular hydrogen: 20 min per day of 3% H2 during 4 weeks

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Applied Bioenergetics Lab at Faculty of Sport and PE; 🇷🇸 Novi Sad, Vojvodina, Serbia