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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
66
University of Washington Medical Center
Seattle, Washington, United States
Change in 6 minute walking distance (6MWD) at the end of study intervention compared to baseline
Time frame: 4 months
Percent change from baseline in ATP max (maximal ATP synthesis rate) in hand skeletal muscle (via Magnetic Resonance Spectroscopy)
Time frame: 2, 4 months
Percent change from baseline in contraction number during a hand muscle fatigue test
Time frame: 2, 4 months
Percent change from baseline in ATP max (maximum ATP synthesis rate) in leg skeletal muscle (via MRS)
Time frame: 4 months
Percent change from baseline in contraction number during a leg muscle fatigue test
Time frame: 4 months
Change in Short Physical Performance Battery (SPPB) scores at the end of study intervention compared to baseline
Time frame: 4 months
Change in exercise tolerance compared to baseline (via cycle ergometry)
Time frame: 4 months
Change in hand grip strength at the end of study intervention compared to baseline
Time frame: 4 months
Change in leg muscle strength (1-RM and 10-RM) at the end of study intervention compared to baseline
Time frame: 4 months
Change in muscle size (cross-sectional area of the muscles) at the end of study intervention compared to baseline
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Time frame: 4 months
Change in mitochondrial function on muscle biopsy samples at the end of study intervention compared to baseline (via respirometry)
Time frame: 4 months
Effect of AMAZ-02 on mitochondrial gene and protein expression in muscle tissue
Time frame: 4 months
Effect of AMAZ-02 on plasma acylcarnitines
Time frame: 4 months
Effect of AMAZ-02 on quality of life questionnaire (SF36)
Time frame: 4 months
Change from baseline in plasma lipid profile
Time frame: 4 months
Change from baseline in plasma for circulating biomarkers (myostatin, follistatin)
Time frame: 4 months