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| Name | Class |
|---|---|
| Stealth BioTherapeutics Inc. | INDUSTRY |
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This study will utilize a daily dose of elamipetide for 4 weeks and will screen a sufficient number of subjects for 30 subjects to enroll in the study. The planned duration of the study includes baseline measurement, followed by 4 weeks intervention period, a midpoint (2week ±3days) check-in phone interview, and post intervention visits that mirror the baseline visits. After the last injection, subjects will enter the 2-week follow-up period, concluded by the end-of-study contact.
This study will be a Phase 2a, open-label, single-arm study enrolling older adults subjects with lower function. The primary objective of this study is to evaluate the safety and tolerability of elamipretide, given as daily subcutaneous injection over 4 weeks. Secondary endpoints will test whether the administration of elamipretide results in changes in blood biomarkers of inflammation and improved cognitive and mobility functional performance in an older adult population. This study will be conducted in strict compliance with the protocol, current Good Clinical Practice (GCP) and all Food and Drug Administration (FDA) guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety and tolerability of daily subcutaneous injection of elamipretide | Other | single arm ELAM intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elamipretide will be supplied as a sterile 5.0 mL single-patient, multi-dose glass vial containing 3.75 mL of elamipretide solution (elamipretide [80 mg/mL], phosphate buffer, and benzyl alcohol) | Drug | Primary Study Objective To evaluate the safety and tolerability of daily subcutaneous injections of elamipetide for 4 weeks in adults aged 65-80 Secondary Objective To assess inflammatory biomarker changes with 4-week daily injection of elamipetide on healthy aging To assess the skeletal muscle health in older subjects with lower aerobic capacity (cardiovascular health) To assess cognitive function changes with 4-week SC daily injection of elamipetide |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of daily subcutaneous injections of elamipetide: Number of participants with treatment-related adverse events and Number of participants completed 4 weeks of injection | 4 week |
| Measure | Description | Time Frame |
|---|---|---|
| blood inflammation markers | levels of BDNF, VEGF, IGF-1, IL-6 | up to 5 months from first enrollment |
| blood inflammation marker | level of TNF-a |
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Inclusion Criteria:
Anti-seizure medications
Exclusion Criteria:
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 study or may influence either the results of the study or the subject's ability to participate in the study
Presence of severe renal disease (eGFR <30 mL/min) or hepatic disease (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2x the upper limit of normal) as evidenced by laboratory results at Screening.
Have a history of rhabdomyolysis
Have been hospitalized within 3 months prior to screening for major atherosclerotic events (e.g., myocardial infarction, target-vessel revascularization, coronary bypass surgery or stroke) or other major medical condition (as deemed by the primary investigator)
Are currently enrolled in a clinical study involving an investigational product or non- approved use of a drug or device or concurrently enrolled in any other type of medical research judged to be scientifically or medically incompatible with this study
Have participated within the last 30 days of screening visit in a clinical study involving an investigational product.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophia Liu, PhD | Contact | 206-543-0209 | sophia21@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| David Marcinek, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Recruiting | Seattle | Washington | 98109 | United States |
Data will be published and listed on clinical trial.gov
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|
| up to 5 months from first enrollment |
| Delta 6 minute walk test | Change in distance walked in 6 minutes following 4 weeks of intervention | 4-6 weeks after enrollment |
| Delta cognitive function score | MoCA to access cognitive function from different domains. MoCA scale is 0-30 with scores >26 indicating normal cognitive function. This is measured by a scale the higher means better function. Trail marking A&B time faster is better; Stroop timed test for attention, processing speed, and executive control. | 4-6 weeks after enrollment |
| Delta skeletal muscle strength | The investigators will measure the change in muscle strength on a 1 rep knee extensor assay following 4 weeks of intervention | 4-6 weeks from enrollment |
| ID | Term |
|---|---|
| C506540 | arginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamide |
| D019905 | Benzyl Alcohol |
| ID | Term |
|---|---|
| D001592 | Benzyl Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D001593 | Benzyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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