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| Name | Class |
|---|---|
| Biogen | INDUSTRY |
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This is a single center, prospective biomarker study to evaluate serum levels of TWEAK and expression levels of TWEAK and Fn14 in muscle biopsies from patients with sarcopenia as well as healthy, physically active controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| subjects with sarcopenia | Screening Procedures (Physical Exam, Height & Weight, Vitals, Medical History, CHAMPS, DXA Scan, Physical Performance Testing, Muscle Strength Testing, Blood Collection) Day 1 (target +/- 2 days) Outpatient Muscle Biopsy (Vitals, Blood Collection, Muscle Biopsy, update Concomitant Therapy and Procedure-Related AEs/SAEs) Day 14 (target +/- 2 days) Safety Follow-up Visit (Vitals, Blood Collection, update Concomitant Therapy and Procedure-Related AEs/SAEs) |
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| healthy, physically-active controls | Screening Procedures (Physical Exam, Height & Weight, Vitals, Medical History, CHAMPS, DXA Scan, Physical Performance Testing, Muscle Strength Testing, Blood Collection) Day 1 (target +/- 2 days) Outpatient Muscle Biopsy (Vitals, Blood Collection, Muscle Biopsy, update Concomitant Therapy and Procedure-Related AEs/SAEs) Day 14 (target +/- 2 days) Safety Follow-up Visit (Vitals, Blood Collection, update Concomitant Therapy and Procedure-Related AEs/SAEs) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Outpatient Muscle Biopsy | Procedure | Outpatient Muscle Biopsy involving skeletal muscle sample collected from the vastus lateralis muscle |
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| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration of TWEAK at day 1 | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Relative expression levels of TWEAK mRNA in muscle biopsy at day 1 | Day 1 | |
| Relative expression levels of Fn14 mRNA in muscle biopsy at day 1 | Day 1 | |
| Correlation between serum TWEAK levels and muscle strength |
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Inclusion Criteria:
To be eligible to participate in this study, all candidates must meet the following eligibility criteria at Baseline or at the time point specified in the individual eligibility criterion listed:
All Participants
1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations
Subjects with Sarcopenia
Healthy Controls
Exclusion Criteria:
Candidates will be excluded from study entry if any of the following exclusion criteria exist at Screening:
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Subjects over age 65 Subjects with Sarcopenia Subjects who are healthy, physically-active controls
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| Name | Affiliation | Role |
|---|---|---|
| Stephen D Anton, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Institute on Aging | Gainesville | Florida | 32611 | United States |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Muscle biopsy samples may be retained for mRNA analysis
| Day 1 |
| Incidence of AEs and SAEs | Screening through Day 14 |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |