- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07563777
100-Year Human Aging Study
100-Year Human Aging Study: Prospective Longitudinal Validation of Multi-System Health Measurements Against Mortality and Aging Outcomes
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
All currently existing longevity measures are surrogate endpoints that have not been prospectively validated against actual mortality and aging outcomes. The 100-Year Human Aging Study is a prospective, pragmatic, observational trial that addresses this gap by enrolling participants in comprehensive clinical screening and following them longitudinally until death to determine which measurements - alone and in combination - are predictive of mortality, serious disease, and functional disability.
The study prioritizes dynamic measurements: the physiological, cognitive, social, and environmental capacities that change with aging and are most likely to carry predictive signal for mortality and functional outcomes. These include cardiorespiratory fitness (cardiopulmonary exercise testing with ventilatory threshold analysis), strength (grip, explosive power, functional movement), mobility and balance, neurocognitive performance, sensory function (vision, hearing, smell, light touch), and metabolic function (oral glucose tolerance, continuous glucose monitoring), in addition to other testing. Structural and imaging assessments include body composition and bone mineral density by DEXA, echocardiography, resting and stress electrocardiography, spirometry, retinal fundus photography, and vascular ultrasound. Laboratory measures are drawn on-site and processed through a CLIA-certified reference laboratory. Complete medical, surgical, family, social, occupational, and environmental histories are obtained at each visit.
Participation ranges from single-service visits - including standalone DEXA, cardiopulmonary exercise testing, laboratory panel testing, and sleep studies - to the full two-visit comprehensive screening battery. All participation pathways contribute clinical data to the longitudinal mortality and aging outcomes linkage framework regardless of service level. Participants are encouraged to return for repeat testing to build longitudinal health trajectories across the lifespan.
At enrollment and across longitudinal follow-up, the study platform generates individualized investigational constructs including biological age estimate, predicted death age, and predicted cause of death profile. These are explicitly investigational hypotheses, not validated clinical standards. Their predictive validity relative to actual mortality, aging outcomes, and functional disability is a central scientific question this study is designed to answer, both for individual measures and for composite multi-system models.
All data are archived in their highest-dimensional raw form to preserve the ability to apply future analytical methods retroactively. Participants are followed with periodic contact and offered repeat screening throughout the lifespan. Longitudinal outcomes ascertainment includes all-cause mortality, cause-specific mortality, incident serious health events, chronic disease diagnosis, functional independence, disability status, and health behavior change.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: William E Brandenburg, MD
- Numero di telefono: 3035010016
- Email: info@longevitymetrics.org
Luoghi di studio
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Colorado
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Boulder, Colorado, Stati Uniti, 80301
- Reclutamento
- Longevity Metrics
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Contatto:
- William E Brandenburg, MD
- Numero di telefono: 3035010016
- Email: info@longevitymetrics.org
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Age 18 years or older
- Willing and able to provide written informed consent, or enrollment with consent of a legally authorized representative
- Willing to participate in longitudinal follow-up
Exclusion Criteria:
- Age under 18 years
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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All-Cause Mortality
Lasso di tempo: From enrollment until death, assessed periodically, up to 100 years
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Vital status ascertained through longitudinal follow-up contact, mortality record linkage, and health data network linkage using probabilistic matching on name, date of birth, and address history.
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From enrollment until death, assessed periodically, up to 100 years
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Cause-Specific Mortality
Lasso di tempo: From enrollment until death, assessed periodically, up to 100 years
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Cause of death ascertained via death certificate and mortality record linkage.
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From enrollment until death, assessed periodically, up to 100 years
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Cause-Specific Mortality Prediction Accuracy
Lasso di tempo: From enrollment until death, assessed periodically, up to 100 years
|
Concordance between predicted cause of death profile generated at enrollment and actual cause of death ascertained at follow-up.
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From enrollment until death, assessed periodically, up to 100 years
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Incident Serious Adverse Health Events
Lasso di tempo: Periodically from enrollment until death, up to 100 years
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New diagnosis of myocardial infarction, stroke, cancer, dementia, heart failure, atrial fibrillation, sepsis, venous thromboembolism, COPD, chronic hypoxia, or major fracture ascertained via periodic follow-up contact and health data network linkage.
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Periodically from enrollment until death, up to 100 years
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Incident Chronic Disease
Lasso di tempo: Periodically from enrollment until death, up to 100 years
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New diagnosis of type 2 diabetes, hypertension, COPD, chronic kidney disease, metabolic syndrome, or osteoporosis ascertained via self-report and health data network linkage.
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Periodically from enrollment until death, up to 100 years
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Functional Independence and Disability Status
Lasso di tempo: Periodically from enrollment until death, up to 100 years
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Activities of daily living, instrumental activities of daily living, and self-reported disability status ascertained via periodic health survey using validated open-source instruments.
Higher composite scores indicate greater functional independence.
Specific instruments will be selected prior to first follow-up contact and documented in the statistical analysis plan.
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Periodically from enrollment until death, up to 100 years
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Biological Age Estimate Prediction Accuracy
Lasso di tempo: Periodically from enrollment until death, up to 100 years
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Concordance between investigational biological age estimate and actual mortality outcomes at longitudinal follow-up.
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Periodically from enrollment until death, up to 100 years
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Health Behavior Change: Composite Self-Report and Repeat Screening Index
Lasso di tempo: Periodically from enrollment until death, up to 100 years
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Health behavior change assessed through two complementary measures aggregated into a single index: validated composite self-report survey administered at periodic follow-up, and change in pre-specified clinical measurements at repeat screening.
Improvement in objective clinical measurements (cardiorespiratory fitness, body composition, metabolic biomarkers, and related parameters) serves as the primary behavioral activation signal.
Self-report domains including health behaviors and preventive care utilization provide supporting context.
Both are combined into a single participant-level health activation index.
Higher scores indicate greater engagement with health-promoting behaviors and measurable clinical improvement.
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Periodically from enrollment until death, up to 100 years
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Multi-System Predictor Modeling: Concordance Statistic
Lasso di tempo: Periodically from enrollment until death, up to 100 years
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Predictive model performance quantified by concordance statistic (C-statistic) assessing the accuracy of a unified multi-domain measurement framework in predicting all-cause mortality and incident serious disease.
The framework integrates clinical, biological, behavioral, social, occupational, and environmental data into a single composite predictive model.
Analyses are reported as a single C-statistic for the full composite model, with pre-specified secondary reporting of C-statistics for individual predictor domains and domain combinations to identify which inputs are independently predictive, redundant, or synergistic.
All analyses converge on the same unit of measure and the same outcome endpoints.
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Periodically from enrollment until death, up to 100 years
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: William E Brandenburg, MD, Longevity Metrics, Inc.
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- Composizione corporea
- Longevità
- Salute della popolazione
- Medicina preventiva
- Declino funzionale
- Durata della salute
- Test da sforzo cardiopolmonare
- Invecchiamento biologico
- Screening preventivo
- Prestazione umana
- Aspettativa di vita
- Previsione della Mortalità
- Surrogate Endpoint Validation
- Longitudinal Cohort
- Biomarker Validation
- Centenarian
Termini MeSH pertinenti aggiuntivi
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Disordini mentali
- Processi patologici
- Malattie metaboliche
- Disturbi neurocognitivi
- Disturbi del metabolismo del glucosio
- Disturbi cognitivi
- Resistenza all'insulina
- Iperinsulinismo
- Condizioni patologiche, segni e sintomi
- Malattie nutrizionali e metaboliche
- Fragilità
- Neoplasie
- Disfunzione cognitiva
- Malattia cardiovascolare
- Sindrome metabolica
- Malattie muscoloscheletriche
- Demenza
Altri numeri di identificazione dello studio
- 100Year
- IORG0012336 (Altro identificatore: OHRP)
- IRB00014601 (Altro identificatore: OHRP)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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