- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07563777
100-Year Human Aging Study
100-Year Human Aging Study: Prospective Longitudinal Validation of Multi-System Health Measurements Against Mortality and Aging Outcomes
Visão geral do estudo
Status
Condições
- Doenças cardiovasculares
- Neoplasias
- Mortalidade
- Doenças musculoesqueléticas
- Disfunção cognitiva
- Síndrome metabólica
- Demência
- Fragilidade
- Envelhecimento
- Atividades do dia a dia
- Deficiência Física
- Doença Neurodegenerativa
- Envelhecer bem
- Mortalidade por todas as causas
- Qualidade de vida relacionada com saúde
Intervenção / Tratamento
Descrição detalhada
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.
Study sites and participation pathways. The 100-Year Human Aging Study is conducted across all Longevity Metrics participation pathways, current and future: the Boulder Human Performance Lab (fixed flagship laboratory); mobile screening units including the Health Ahead Bus; any additional fixed or mobile Longevity Metrics laboratory established during the study period; and an online participation pathway through which participants enroll and contribute structured data without in-person screening. All pathways operate under a single protocol with identical procedures, data management, informed consent, and safety standards.
This study is one of four that compound into one system. The Human Observatory Study (NCT07646782) validates sociodemographic and environmental data against the same outcomes, and receives each model's geographic residuals. The Health Ahead Comparative Effectiveness Study (NCT07669168) moves the screening toward increasing automation and mobility while maintaining quality. The Longevity Metrics AI/ML Development Study (NCT pending approval) builds the models that make automation, prediction, and broad utilization possible. This study supplies the clinical data and validates what it means for health, disease, disability, and death.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: William E Brandenburg, MD
- Número de telefone: 3035010016
- E-mail: info@longevitymetrics.org
Locais de estudo
-
-
Colorado
-
Boulder, Colorado, Estados Unidos, 80301
- Recrutamento
- Longevity Metrics
-
Contato:
- William E Brandenburg, MD
- Número de telefone: 3035010016
- E-mail: info@longevitymetrics.org
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
All-Cause Mortality
Prazo: From enrollment until death, assessed periodically, up to 100 years
|
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.
|
From enrollment until death, assessed periodically, up to 100 years
|
|
Cause-Specific Mortality
Prazo: From enrollment until death, assessed periodically, up to 100 years
|
Cause of death ascertained via death certificate and mortality record linkage.
|
From enrollment until death, assessed periodically, up to 100 years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Cause-Specific Mortality Prediction Accuracy
Prazo: 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.
|
From enrollment until death, assessed periodically, up to 100 years
|
|
Incident Serious Adverse Health Events
Prazo: Periodically from enrollment until death, up to 100 years
|
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.
|
Periodically from enrollment until death, up to 100 years
|
|
Incident Chronic Disease
Prazo: Periodically from enrollment until death, up to 100 years
|
New diagnosis of type 2 diabetes, hypertension, COPD, chronic kidney disease, metabolic syndrome, or osteoporosis ascertained via self-report and health data network linkage.
|
Periodically from enrollment until death, up to 100 years
|
|
Functional Independence and Disability Status
Prazo: Periodically from enrollment until death, up to 100 years
|
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.
|
Periodically from enrollment until death, up to 100 years
|
|
Biological Age Estimate Prediction Accuracy
Prazo: Periodically from enrollment until death, up to 100 years
|
Concordance between investigational biological age estimate and actual mortality outcomes at longitudinal follow-up.
|
Periodically from enrollment until death, up to 100 years
|
|
Health Behavior Change: Composite Self-Report and Repeat Screening Index
Prazo: Periodically from enrollment until death, up to 100 years
|
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.
|
Periodically from enrollment until death, up to 100 years
|
|
Multi-System Predictor Modeling: Predictive Performance
Prazo: Periodically from enrollment until death, up to 100 years
|
Performance 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 model.
Performance is reported for the full composite model, with pre-specified secondary reporting for individual predictor domains and domain combinations to identify which inputs are independently predictive, which are redundant, and which combinations provide additive or synergistic predictive value.
Metrics are specified in the statistical analysis plan.
|
Periodically from enrollment until death, up to 100 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: William E Brandenburg, MD, Longevity Metrics, Inc.
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
- Composição do corpo
- Longevidade
- Saúde da População
- Medicina preventiva
- Declínio Funcional
- Período de saúde
- Teste Cardiopulmonar de Exercício
- Envelhecimento Biológico
- Rastreio Preventivo
- Desempenho Humano
- Expectativa de vida
- Previsão de Mortalidade
- Surrogate Endpoint Validation
- Longitudinal Cohort
- Biomarker Validation
- Centenarian
Termos MeSH relevantes adicionais
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Transtornos Mentais, Desordem Mental
- Processos Patológicos
- Doenças Metabólicas
- Distúrbios Neurocognitivos
- Distúrbios do Metabolismo da Glicose
- Distúrbios Cognitivos
- Resistência a insulina
- Hiperinsulinismo
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Fragilidade
- Neoplasias
- Disfunção cognitiva
- Doenças cardiovasculares
- Síndrome metabólica
- Doenças musculoesqueléticas
- Demência
Outros números de identificação do estudo
- 100Year
- IORG0012336 (Outro identificador: OHRP)
- IRB00014601 (Outro identificador: OHRP)
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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