Phase 2CompletedGeroscience intervention
ELITE: Deep Profiling and Algorithmic Polytherapy to Map Individual Response in Healthy Aging
Evidence-Based Longevity Interventions and Targeted Engagement (E.L.I.T.E.)
- Sponsor
- Sheba Medical Center (Government)
- Enrolment
- 31 enrolled
- Conditions
- Healthy Aging
- Interventions
- AgeBiotics AB-01; AgeBiotics AB-02; Metformin; semaglutide; empagliflozin
- Ages
- adults, older adults
- Registry
- NCT07871799, ISRCTN84791030
Full record on ClinicalTrials.gov
From the registry
ELITE, Evidence-Based Longevity Interventions and Targeted Engagement, was a randomized, open-label, two-active-arm Phase IIa pilot conducted at Sheba Medical Center in Ramat Gan, Israel. The purpose of ELITE was to characterize individual response to multidomain healthy-aging interventions over approximately eight weeks by combining a clinical measure of muscular, immune and cognitive function with frequent digital monitoring between study visits. The primary outcome was change from baseline to Week 8 in the Muscular-Immune-Cognitive Composite (MIC-C). The study hypothesis was that repeated digital measurements could capture the trajectory of individual response over time and relate that trajectory to clinical change measured at Week 8. Prespecified secondary outcomes included safety, study completion and overall protocol adherence. The protocol-defined intervention was algorithmic polytherapy, integrating a multicomponent pharmacologic and investigational-product regimen with longitudinal digital response monitoring and physician-supervised decision support. In this eight-week…
Primary outcomes
- Change From Baseline in Muscular-Immune-Cognitive Composite (MIC-C) Score at Week 8
History
Registered
Primary completion
Started