Sarcopenia
Conditions
Keywords
Sarcopenia
Brief summary
The goal of this clinical trial is to primarily evaluate the efficacy of AVTR101 to placebo on physical performance in sarcopenia patients. Participants will: Take AVTR101 or a placebo three times daily for 12 weeks Visit the clinic once every 4 weeks for checkups and tests
Interventions
DRUGAVTR101
three times daily
DRUGPlacebo
three times daily
Sponsors
Seoul National University Bundang Hospital
Ajou University School of Medicine
SMG-SNU Boramae Medical Center
Asan Medical Center
Aventi Biotechnology Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women aged 65 years or older at the time of screening * Appendicular skeletal muscle mass (ASM) measured by dual-energy x-ray absorptiometry (DXA), men \< 7.0 kg/m2, women \< 5.4 kg/m2 * Handgrip strength, men \< 28 kg, women \< 18 kg or 5-times sit-to-stand ≥ 12 second or 6 meter walking speed \< 1.0 m/s * nutrition status confirmed by mini nutritional assessment (MNA) is higher than 8 at the time of screening * body weight ≥ 35 kg and BMI is between 15\ 30 kg/m2 at the time of screening * After fully understanding the written consent, which includes compliance with the requirements and restrictions listed in the trial protocol and describes the overall nature and purpose of the clinical trial, including potential risks and side effects, the subject (or representative) voluntarily A person who signed a written consent form as
Exclusion criteria
* Patients with neuromuscular or nervous system diseases (e.g. Parkinson's disease, Lou Gehrig's disease, stroke affecting lower extremity function, muscular dystrophy, epilepsy, multiple sclerosis, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SPPB total score at 12 weeks | From enrollment to the end of treatment at 12 weeks | The SPPB evaluates lower extremity function through three components: standing balance, usual gait speed, and chair stand. Each component is scored on a scale from 0 to 4, with the total score ranging from 0 to 12. A higher score reflects a higher level of function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 5-STS time | From enrollment to the end of treatment at 4, 8, 12 weeks | Change in 5-STS time required at 4, 8, 12 weeks after administration compared to baseline |
| Change in 6m walk speed | From enrollment to the end of treatment at 4, 8, 12 weeks | Change in 6m walk speed at 4, 8, 12 weeks after administration compared to baseline |
| Change in ASM measured by DXA | From enrollment to the end of treatment at 12 weeks | Change in ASM measured by DXA at 12 weeks after administration compared to baseline |
| Change in SPPB total score at 4, 8 weeks | From enrollment to the end of treatment at 4, 8 weeks | The SPPB evaluates lower extremity function through three components: standing balance, usual gait speed, and chair stand. Each component is scored on a scale from 0 to 4, with the total score ranging from 0 to 12. A higher score reflects a higher level of function. |
| Change in SARC-F total score | From enrollment to the end of treatment at 12 weeks | The SARC-F is a simple, 5-item screening questionnaire designed to rapidly assess the risk of sarcopenia in older adults. It evaluates five components: Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls. Each item is scored from 0 to 2, resulting in a total score ranging from 0 to 10, with a score of 4 or higher indicating an increased risk of sarcopenia. |
| Change in SarQoL: total score | From enrollment to the end of treatment at 12 weeks | The SarQoL (Sarcopenia and Quality of Life) is a validated, sarcopenia-specific quality of life questionnaire designed for older adults. It consists of 22 questions across seven domains: physical and mental health, locomotion, body composition, functionality, activities of daily living, leisure activities, and fears. The questionnaire produces a total score ranging from 0 to 100, with higher scores indicating better quality of life. |
| Change in handgrip strength | From enrollment to the end of treatment at 4, 8, 12 weeks | Change in handgrip strength at 4, 8, 12 weeks after administration compared to baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood chemistry test: γ-GT | 0, 4, 8, 12 week | Laboratory tests - Blood chemistry test, γ-GT (U/L) |
| Blood chemistry test: Lactic Dehydrogenase | 0, 4, 8, 12 week | Laboratory tests - Blood chemistry test, Lactic Dehydrogenase (U/L) |
| Blood chemistry test: Total Cholesterol | 0, 4, 8, 12 week | Laboratory tests - Blood chemistry test, Total Cholesterol (mg/dL) |
| Urinalysis: Leukocyte | 0, 4, 8, 12 week | Laboratory tests - Urinalysis, Leukocyte (10\^2/uL) |
| Urinalysis: Nitrate | 0, 4, 8, 12 week | Laboratory tests - Urinalysis, Nitrate (mg/dL) |
| Hematology: RBC | 0, 4, 8, 12 week | Laboratory test - hematology, Red Blood Cell (10\^6/uL) |
| Electrocardiogram: heart rate | 0, 4, 8, 12 week | 12-lead ECG (Electrocardiogram) - heart rate (beat per minute, bpm) |
| Electrocardiogram: PR interval | 0, 4, 8, 12 week | 12-lead ECG (Electrocardiogram) - PR interval (millisecond, ms) |
| Electrocardiogram: QT interval uncorrected | 0, 4, 8, 12 week | 12-lead ECG (Electrocardiogram) - QT interval uncorrected (millisecond, ms) |
| Electrocardiogram: QTc interval | 0, 4, 8, 12 week | 12-lead ECG (Electrocardiogram) - QTc interval (millisecond, ms) |
| Electrocardiogram: QRS duration | 0, 4, 8, 12 week | 12-lead ECG (Electrocardiogram) - QRS duration (millisecond, ms) |
| Electrocardiogram: date and time | 0, 4, 8, 12 week | 12-lead ECG (Electrocardiogram) - date and time of ECG |
| Hematology: Hemoglobin | 0, 4, 8, 12 week | Laboratory test - hematology, Hemoglobin (g/dL) |
| Hematology: Hematocrit | 0, 4, 8, 12 week | Laboratory test - hematology, Hematocrit (%) |
| Blood chemistry test: Ca | 0, 4, 8, 12 week | Laboratory tests - Blood chemistry test, Ca (mg/dL) |
| Blood chemistry test: ALT | 0, 4, 8, 12 week | Laboratory tests - Blood chemistry test, ALT (U/L) |
| Blood chemistry test: AST | 0, 4, 8, 12 week | Laboratory tests - Blood chemistry test, AST (U/L) |
| Blood chemistry test: ALP | 0, 4, 8, 12 week | Laboratory tests - Blood chemistry test, ALP (U/L) |
| Blood chemistry test: Total bilirubin (mg/dL) | 0, 4, 8, 12 week | Laboratory tests - Blood chemistry test, Total bilirubin (mg/dL) |
Countries
South Korea
Outcome results
None listed