Bioenergetics and Muscle Function Improvement With AMAZ-02 in Elderly Skeletal Muscle (ENERGIZE Trial)
Not Applicable
Completed
- Conditions
- Mitochondrial Function, BioenergeticsMuscle FunctionAging
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Mitopure
- Registration Number
- NCT03283462
- Lead Sponsor
- Amazentis SA
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
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.
- Body mass index <18 or >32 kg/m2
- Severe chronic kidney disease requiring treatment with hemodialysis or peritoneal dialysis.
- Additional laboratory abnormalities determined as clinically significant by the Investigator.
- Clinically significant abnormalities on physical examination (as judged by the Investigator)
- Clinically significant and chronic uncontrolled renal, hepatic, pulmonary, endocrine, neurologic disorders, bone, or gastrointestinal system dysfunction
- History of seizures or epilepsy
- History of serious mental illness as judged by the Investigator
- Oral temperature >37.5°C at the time of the physical
- Suspicion, or recent history, of alcohol or substance abuse or tobacco use
- Subjects who in the opinion of the Investigator have a clinically significant abnormal 12-lead ECG during the screening period. Presence of atrial fibrillation, varying degrees of AV block, existence of a left bundle branch block, or evidence of previous myocardial infarction.
- Subjects who are either unwilling to agree to refrain from using or are found to be using supplementary antioxidant vitamins (e.g., Coenzyme Q10, resveratrol, L-carnitine) from 7 days prior to dosing and throughout the treatment period
- Subjects who are either unwilling to agree to refrain from using or are found to be using the following dietary restrictions (pomegranate juice, walnuts, pecans, strawberry, raspberry blackberry) from 7 days prior to dosing and throughout the treatment period
- Are currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have participated, within the last 30 days from a clinical trial involving an investigational product. If the previous investigational product has a long half life, 3 months or 5 half-lives (whichever is longer) should have passed
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Mitopure Mitopure -
- Primary Outcome Measures
Name Time Method Change in 6 minute walking distance (6MWD) at the end of study intervention compared to baseline 4 months Percent change from baseline in ATP max (maximal ATP synthesis rate) in hand skeletal muscle (via Magnetic Resonance Spectroscopy) 2, 4 months
- Secondary Outcome Measures
Name Time Method Percent change from baseline in contraction number during a hand muscle fatigue test 2, 4 months Percent change from baseline in ATP max (maximum ATP synthesis rate) in leg skeletal muscle (via MRS) 4 months Percent change from baseline in contraction number during a leg muscle fatigue test 4 months Change in Short Physical Performance Battery (SPPB) scores at the end of study intervention compared to baseline 4 months Change in exercise tolerance compared to baseline (via cycle ergometry) 4 months Change in hand grip strength at the end of study intervention compared to baseline 4 months Change in leg muscle strength (1-RM and 10-RM) at the end of study intervention compared to baseline 4 months Change in muscle size (cross-sectional area of the muscles) at the end of study intervention compared to baseline 4 months Change in mitochondrial function on muscle biopsy samples at the end of study intervention compared to baseline (via respirometry) 4 months Effect of AMAZ-02 on mitochondrial gene and protein expression in muscle tissue 4 months Effect of AMAZ-02 on plasma acylcarnitines 4 months Effect of AMAZ-02 on quality of life questionnaire (SF36) 4 months Change from baseline in plasma lipid profile 4 months Change from baseline in plasma for circulating biomarkers (myostatin, follistatin) 4 months
Trial Locations
- Locations (1)
University of Washington Medical Center
🇺🇸Seattle, Washington, United States