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Esplorazione della Funzione del Sistema Nervoso Simpatico negli Individui con Sindrome di Down (DIVE)

9 ottobre 2026 aggiornato da: University of Colorado, Denver

Investigazione sulla Disautonomia negli Individui con Sindrome di Down: Studio DIVE

Down syndrome (DS), the most common genetic cause of intellectual disability, is associated with widespread organ dysfunction, including abnormalities in the autonomic nervous system (ANS). The ANS regulates critical functions such as heart rate (HR) and blood pressure (BP), both essential for maintaining homeostasis and supporting physical activity. Individuals with DS often exhibit blunted HR responses to exercise-typically ~30 beats per minute below expected levels-suggesting reduced sympathetic nervous system (SNS) activity. The SNS governs rapid changes in HR and BP during stress by releasing catecholamines: epinephrine (from the adrenal medulla) and norepinephrine (from sympathetic nerve endings). Despite its importance, SNS function has not been comprehensively assessed among individuals with DS.

This study addresses a critical knowledge gap by evaluating SNS responses to physiological stressors in individuals with DS. The investigators will measure beat-to-beat HR and BP, along with plasma catecholamine levels, in response to sympathetic activation, comparing individuals with DS to age- and sex-matched controls. Understanding the mechanisms of SNS dysfunction in DS is vital, as it likely underlies reduced exercise capacity and contributes to broader clinical challenges. These insights may guide targeted interventions to improve cardiovascular function, physical capacity, and overall quality of life in this understudied population.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Evolution has equipped each species with instinctual defense mechanisms to cope with environmental stressors, ensuring survival. Many of these mechanisms are driven by activation of the sympathetic nervous system (SNS), which orchestrates the "fight or flight" response. Systemic SNS activation extends across all organ systems, triggering the release of catecholamines to elevate heart rate (HR) and increase blood pressure (BP) to meet the heightened metabolic demands of the stressor and ensure the delivery of oxygen-rich blood to active tissues. Exercise, a potent sympathoexcitatory stressor, poses a major challenge to the oxygen transport system, requiring coordinated organ system function to increase both HR and BP. Dysregulated SNS activation can impair oxygen delivery, leading to reduced work capacity, quality of life, and is an independent predictor of morbidity and premature mortality. Therefore, experimental approaches to understand SNS activation in populations with reduced work capacity and premature morbidity, mortality is of upmost importance for improving health outcomes and quality of life on a population level.

Down syndrome (DS) is the most common chromosomal abnormality in the human population, with widespread effects across numerous tissues and organ systems, including accelerated biological aging. Individuals with DS exhibit reduced work capacity, with maximal HRs ~30 beats below normal, and face higher rates of premature morbidity and mortality than the general population. Notably, individuals with DS demonstrate blunted catecholamine response to the sympathetic stressor of maximal exercise, suggesting diminished SNS activation. Recent literature from this PI suggests altered peripheral blood flow and BP regulation among individuals with DS during large muscle mass exercise which immolates walking, or running- critical for survival. These findings align with recent evidence of hypoxic signaling, elevated heme metabolism, and stress erythropoiesis across the lifespan in this population. Together, these data suggest that impaired oxygen delivery, potentially linked to SNS dysregulation, may be more widespread in DS than previously recognized.

However, the role of SNS activation in the context of daily stressors which elevate both HR and BP, remains unclear. Understanding the mechanisms underlying SNS dysfunction in DS is crucial, as it likely contributes to many clinical and developmental challenges, including the underlying reduced work capacity and suggested autonomic dysfunction observed in this population. Addressing this gap may enable targeted therapies to enhance survival, longevity, and quality of life for individuals with DS. The investigators aim to systematically evaluate SNS activation through four stressors which mimic common stressors faced to any individual over the course of a day or lifespan. Through evaluation of plasma catecholamines, the investigators hope to elucidate the mechanisms and impact of catecholamine responses in individuals with DS compared typical responses observed among individuals without DS.

Aim 1. Characterize the catecholamine response to physiological stressors among individuals with DS. The investigators will assess SNS responses in individuals with DS and age- and sex-matched controls. Beat-to-beat HR and BP, along with plasma catecholamine levels will be collected in response to the following sympathetic stressors: A) Cold Stress, B) Handgrip with Post-Exercise Muscle Ischemia, C) Head-up Tilt, and D) Maximal Dynamic Exercise (VO2peak). Metabolomics and proteomics will be performed on the plasma samples and these efforts will help define the manifestations of hormonal SNS dysfunction in individuals with DS.

Tipo di studio

Interventistico

Iscrizione (Stimato)

200

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • Reclutamento
        • Linda Crnic Institute for Down Syndrome, University of Colorado Anschutz Medical Campus
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 50 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • 18-50 yrs old and apparently healthy individuals
  • Ability to understand the study and give assent to participate
  • Has a study partner who can attend all visits for the individuals with DS, and answer questionnaires, provide consent when necessary
  • Corrected or non-existent congenital heart disease
  • Euthyroid or on stable thyroid medication dose for at least 6 months
  • Free from cardiovascular, pulmonary, inflammatory, or metabolic disease in the past 6 months that would prevent participation in study procedures
  • BMI <45kg/m2
  • Ability to tolerate repeated blood draws / catheter placement

Exclusion Criteria:

  • Hypertension (resting systolic blood pressure [SBP] ≥140 and/or diastolic blood pressure [DBP] ≥90 mmHg) this includes those on medications to treat hypertension
  • Hypotension (resting BP of <90/60 mmHg)
  • Cancer in the last six months
  • Any heart-rate-altering medications or any other medication that may modify metabolic responses
  • Self-reported diabetes or use of glucose-lowering medication
  • Tobacco products, including vaping, or marijuana use
  • Currently pregnant
  • Post-menopausal women

Specific Exclusion Criteria for Certain Stressors:

  • Orthopedic limitations that would prohibit exercise or movement for exercise
  • Fracture of limb to be immersed for CPT
  • Open cut or sore on hand to be immersed for CPT
  • Raynaud's syndrome for CPT

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Individuals with Down syndrome

The investigators will be recruiting participants between the ages of 18-50 for the study investigating responses to four sympathetic stressors compared to age and sex matched individuals without Down syndrome.
Altro: Cold Stress

Cold triggers the sympathetic nervous system, known as the 'fight-or-flight' response, which prepares the body to respond to a perceived threat by increasing heart rate, blood pressure, and releasing catecholamines. These measurements will be taken to examine how individuals with DS will respond during a cold stress test.

The investigators are looking at how plasma catecholamines (i.e., Epinephrine, Norepinephrine, and Dopamine), blood pressure, and heart rate are expressed during a cold stress test in individuals with Down syndrome, who have proposed autonomic dysfunction. This study will compare responses among individuals with Down syndrome to a control group without Down syndrome.

Altri nomi:
  • Test del pressore a freddo
  • Acqua Fredda
Altro: Maximal Dynamic Exercise

The investigators are looking at how plasma catecholamines (i.e., Epinephrine, Norepinephrine, and Dopamine), blood pressure, and heart rate are expressed during a treadmill maximal exercise test in individuals with Down syndrome, who have proposed autonomic dysfunction. This study will compare responses among individuals with Down syndrome to a control group without Down syndrome.

Altri nomi:
  • VO2picco
  • Esercizio su Tapis Roulant
Altro: Isometric Handgrip Exercise with Post-Exercise Muscle Ischemia

The investigators are looking at how plasma catecholamines (i.e., Epinephrine, Norepinephrine, and Dopamine), blood pressure, and heart rate are expressed during a isometric handgrip exercise followed by an ischemic period which will be induced by a blood pressure cuff in individuals with Down syndrome, who have proposed autonomic dysfunction. This study will compare responses among individuals with Down syndrome to a control group without Down syndrome.

Altri nomi:
  • Handgrip
  • Post-Exercise Muscle Ischemia
Altro: Head-up Tilt Table Test

The investigators are looking at how plasma catecholamines (i.e., Epinephrine, Norepinephrine, and Dopamine), blood pressure, and heart rate are expressed during passive head-up tilt testing which is a standardized, noninvasive clinical and research procedure used to characterize cardiovascular autonomic responses to orthostatic stress, among individuals with Down syndrome, who have proposed autonomic dysfunction.

Altri nomi:
  • Tavolo inclinabile
  • Orthostatic Stress
Sperimentale: Individuals without Down syndrome

The investigators will be recruiting individuals without Down syndrome between the ages of 18-50 to serve as the comparisons for individuals with Down syndrome across the four sympathetic stressors.
Altro: Cold Stress

Cold triggers the sympathetic nervous system, known as the 'fight-or-flight' response, which prepares the body to respond to a perceived threat by increasing heart rate, blood pressure, and releasing catecholamines. These measurements will be taken to examine how individuals with DS will respond during a cold stress test.

The investigators are looking at how plasma catecholamines (i.e., Epinephrine, Norepinephrine, and Dopamine), blood pressure, and heart rate are expressed during a cold stress test in individuals with Down syndrome, who have proposed autonomic dysfunction. This study will compare responses among individuals with Down syndrome to a control group without Down syndrome.

Altri nomi:
  • Test del pressore a freddo
  • Acqua Fredda
Altro: Maximal Dynamic Exercise

The investigators are looking at how plasma catecholamines (i.e., Epinephrine, Norepinephrine, and Dopamine), blood pressure, and heart rate are expressed during a treadmill maximal exercise test in individuals with Down syndrome, who have proposed autonomic dysfunction. This study will compare responses among individuals with Down syndrome to a control group without Down syndrome.

Altri nomi:
  • VO2picco
  • Esercizio su Tapis Roulant
Altro: Isometric Handgrip Exercise with Post-Exercise Muscle Ischemia

The investigators are looking at how plasma catecholamines (i.e., Epinephrine, Norepinephrine, and Dopamine), blood pressure, and heart rate are expressed during a isometric handgrip exercise followed by an ischemic period which will be induced by a blood pressure cuff in individuals with Down syndrome, who have proposed autonomic dysfunction. This study will compare responses among individuals with Down syndrome to a control group without Down syndrome.

Altri nomi:
  • Handgrip
  • Post-Exercise Muscle Ischemia
Altro: Head-up Tilt Table Test

The investigators are looking at how plasma catecholamines (i.e., Epinephrine, Norepinephrine, and Dopamine), blood pressure, and heart rate are expressed during passive head-up tilt testing which is a standardized, noninvasive clinical and research procedure used to characterize cardiovascular autonomic responses to orthostatic stress, among individuals with Down syndrome, who have proposed autonomic dysfunction.

Altri nomi:
  • Tavolo inclinabile
  • Orthostatic Stress

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Seated Baseline Concentration of Plasma Catecholamines
Lasso di tempo: Seated baseline blood draw, prior to stressors

Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the four stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
Seated baseline blood draw, prior to stressors
Standing Baseline Concentration of Plasma Catecholamines
Lasso di tempo: Blood draw will occur in standing position, prior to head up tilt table testing

Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the four stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
Blood draw will occur in standing position, prior to head up tilt table testing
Concentration of Plasma Catecholamines During Cold Pressor Test
Lasso di tempo: During the cold stress test, around or up to 5 minutes

Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the four stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
During the cold stress test, around or up to 5 minutes
Concentration of Plasma Catecholamines During Handgrip Test
Lasso di tempo: Blood draws occur around or up to 2-3 minutes into handgrip test

Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the four stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
Blood draws occur around or up to 2-3 minutes into handgrip test
Concentration of Plasma Catecholamines During Post Exercise Muscle Ischemia
Lasso di tempo: Seated blood draw to occur, around or about 2-3 minutes into post exercise muscle ischemia

Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the four stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
Seated blood draw to occur, around or about 2-3 minutes into post exercise muscle ischemia
Supine Concentration of Plasma Catecholamines
Lasso di tempo: Blood draws during or around 10 minutes of supine rest

Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the four stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
Blood draws during or around 10 minutes of supine rest
Supine Concentration of Plasma Catecholamines, 5 Minutes into Head-Up Tilt
Lasso di tempo: At or around 5 minutes into the head-up tilt table stimulus

Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the four stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
At or around 5 minutes into the head-up tilt table stimulus
Supine Concentration of Plasma Catecholamines, 10 Minutes into Head-Up Tilt
Lasso di tempo: At or around 10 minutes into the head-up tilt table stimulus

Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the four stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
At or around 10 minutes into the head-up tilt table stimulus
Baseline Standing Concentration of Plasma Catecholamines Prior to Maximal Exercise Test
Lasso di tempo: Standing baseline blood draw, prior to maximal exercise test

Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the four stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
Standing baseline blood draw, prior to maximal exercise test
Standing Concentration of Plasma Catecholamines at End of Maximal Exercise Test
Lasso di tempo: This blood draw will occur at the very end or immediately following the maximal exercise test on the treadmill

Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the four stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
This blood draw will occur at the very end or immediately following the maximal exercise test on the treadmill
Standing Concentration of Plasma Catecholamines, 30 Minutes Post Maximal Exercise
Lasso di tempo: This blood draw will occur around 30 minutes following the maximal exercise test on the treadmill

Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the four stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
This blood draw will occur around 30 minutes following the maximal exercise test on the treadmill
Standing Concentration of Plasma Catecholamines, 60 Minutes Post Maximal Exercise
Lasso di tempo: This blood draw will occur at the around 60 minutes following the maximal exercise test on the treadmill

Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the four stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
This blood draw will occur at the around 60 minutes following the maximal exercise test on the treadmill
Seated Baseline Heart Rate, Prior to Cold Pressor Test
Lasso di tempo: Resting seated baseline, prior to cold pressor test, up to or around 5 minutes

Investigators will collect beat-to-beat heart rate recordings in all participants before, during (in some stressors), and after the four stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Resting seated baseline, prior to cold pressor test, up to or around 5 minutes
Heart Rate Collected During Cold Pressor Test
Lasso di tempo: Collected throughout the Cold Pressor Test, around 6 minutes in total

Investigators will collect beat-to-beat heart rate recordings in all participants before, during, and after the four stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Collected throughout the Cold Pressor Test, around 6 minutes in total
Heart Rate, Maximal Exercise Test
Lasso di tempo: Continuous heart rate recordings will take place throughout the maximal aerobic exercise test on the treadmill, up to or around 20 minutes

Investigators will collect beat-to-beat heart rate recordings in all participants before, during, and after the four stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Continuous heart rate recordings will take place throughout the maximal aerobic exercise test on the treadmill, up to or around 20 minutes
Seated Baseline Blood Pressure, Prior to Cold Pressor Test
Lasso di tempo: Resting seated baseline, prior to cold pressor test, up to or around 5 minutes

Investigators will collect beat-to-beat blood pressure recordings in all participants before, during, and after the four stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Resting seated baseline, prior to cold pressor test, up to or around 5 minutes
Blood Pressure Collected During Cold Pressor Test
Lasso di tempo: Collected throughout the Cold Pressor Test, around 6 minutes in total

Investigators will collect beat-to-beat blood pressure recordings in all participants before, during, and after the four stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Collected throughout the Cold Pressor Test, around 6 minutes in total
Heart Rate Collected During Handgrip with Post-Exercise Muscle Ischemia
Lasso di tempo: Collected throughout the Handgrip tests with Post-Exercise Muscle Ischemia, around 12 minutes in total

Investigators will collect beat-to-beat heart rate recordings in all participants before, during, and after the four stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Collected throughout the Handgrip tests with Post-Exercise Muscle Ischemia, around 12 minutes in total
Heart Rate Collected During Head-Up Tilt Table Test
Lasso di tempo: Collected throughout the Head-Up Tilt Table Test, around 25 minutes in total

Investigators will collect beat-to-beat heart rate recordings in all participants before, during, and after the four stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Collected throughout the Head-Up Tilt Table Test, around 25 minutes in total
Blood Pressure Collected During Handgrip Test with Post-Exercise Muscle Ischemia
Lasso di tempo: Collected throughout the handgrip test with post-exercise muscle ischemia, up to or around 12 minutes

Investigators will collect beat-to-beat blood pressure recordings in all participants before, during, and after the four stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Collected throughout the handgrip test with post-exercise muscle ischemia, up to or around 12 minutes
Blood Pressure Collected During Head-Up Tilt Table Test
Lasso di tempo: Collected throughout the head-up tilt table test, around 25 minutes in total

Investigators will collect beat-to-beat blood pressure recordings in all participants before, during, and after the four stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Collected throughout the head-up tilt table test, around 25 minutes in total

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Facial Affective Scale Score, Baseline Assessment
Lasso di tempo: Baseline Assessment of Facial Affective Scale, this will occur prior to any stressors.

Investigators will use the validated 'Facial Affective Scale', which uses a series of nine drawn faces showing various degrees of emotional distress to help participants assess their emotional state. The nine faces represent a range of negative to positive affect, and each face having a specific value between 0.04 (maximum positive affect) and 0.97 (maximum negative affect). The chosen face's corresponding value is the Facial Affective Score. This will take up to or around approximately 5 minutes to complete.
Baseline Assessment of Facial Affective Scale, this will occur prior to any stressors.
Facial Affective Scale Score, Cold Pressor Test, 1.5 Minutes
Lasso di tempo: Assessment occurs around or up to 90 seconds (1.5 minutes) into cold water immersion

Investigators will use the validated 'Facial Affective Scale', which uses a series of nine drawn faces showing various degrees of emotional distress to help participants assess their emotional state. The nine faces represent a range of negative to positive affect, and each face having a specific value between 0.04 (maximum positive affect) and 0.97 (maximum negative affect). The chosen face's corresponding value is the Facial Affective Score.
Assessment occurs around or up to 90 seconds (1.5 minutes) into cold water immersion
Facial Affective Scale Score, Cold Pressor Test, Finale
Lasso di tempo: Assessment occurs immediately following or during the last minute of the Cold Pressor Test, up to or around 6 minutes following placement of arm into cold

Investigators will use the validated 'Facial Affective Scale', which uses a series of nine drawn faces showing various degrees of emotional distress to help participants assess their emotional state. The nine faces represent a range of negative to positive affect, and each face having a specific value between 0.04 (maximum positive affect) and 0.97 (maximum negative affect). The chosen face's corresponding value is the Facial Affective Score.
Assessment occurs immediately following or during the last minute of the Cold Pressor Test, up to or around 6 minutes following placement of arm into cold

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Colorado, Denver

Collaboratori

National Institute on Aging (NIA)
Linda Crnic Institute for Down Syndrome
GLOBAL Down Syndrome Foundation
University of Colorado Colorado Clinical and Translational Sciences Institute

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

6 aprile 2026

Completamento primario (Stimato)

1 dicembre 2029

Completamento dello studio (Stimato)

1 dicembre 2030

Date di iscrizione allo studio

Primo inviato

22 ottobre 2025

Primo inviato che soddisfa i criteri di controllo qualità

17 novembre 2025

Primo Inserito (Effettivo)

20 novembre 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 ottobre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 25-0503
  • T32AG000279 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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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