Bioenergetics and Muscle Function Improvement With AMAZ-02 in Elderly Skeletal Muscle (ENERGIZE T… (NCT03283462) | Clinical Trial Compass
CompletedNot Applicable
Bioenergetics and Muscle Function Improvement With AMAZ-02 in Elderly Skeletal Muscle (ENERGIZE Trial)
United States66 participantsStarted 2018-02-15
Plain-language summary
This is a randomized, double-blind, single-center, placebo-controlled Phase 2 trial enrolling 66 healthy elderly subjects (33 placebo and 33 AMAZ-02 administration) who are ≥65 and ≤ 90 years of age with evidence of low mitochondrial function. AMAZ-02 or placebo will be orally administered for 4 months.
Who can participate
Age range65 Years – 90 Years
SexALL
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Inclusion criteria
✓. Adults ≥65 and ≤90 years of age
✓. Able to travel to and from the University of Washington and Fred Hutch Cancer Research Center (FHCRC)
✓. Informed consent obtained
✓. 6 minute walk distance of \<550 meters
✓. ATP max \< 1mM /sec (in the hand FDI muscle)
Exclusion criteria
✕. Subjects who have significant disease(s) or condition(s) which, in the opinion of the investigator, may put the subject at risk because of their participation in the trial or may influence either the results of the trial or the subject's ability to participate in the trial
✕. Hospitalization within 3 months for major atherosclerotic events (defined as combined incidence of myocardial infarction, urgent target-vessel revascularization, coronary bypass surgery and stroke) and for any hospitalization within 2 months.
✕. Have any metal implants in the right limbs, including non-MRI compatible metal stents, titanium pins/markers, etc.
✕. Have an implanted cardiac pacemaker or other implanted non-MRI compatible cardiac device
✕. Chronic, uncontrolled hypertension as judged by the Investigator (i.e., Baseline SBP \>150 mm Hg, DBP \>90 mm Hg) or a SBP \> 150 mm Hg or DBP \> 95 mm Hg at the time of screening or baseline. If the initial BP reading is above these values, the reading may be repeated one time within 20 minutes of the initial reading.
What they're measuring
1
Change in 6 minute walking distance (6MWD) at the end of study intervention compared to baseline
Timeframe: 4 months
2
Percent change from baseline in ATP max (maximal ATP synthesis rate) in hand skeletal muscle (via Magnetic Resonance Spectroscopy)