Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Actividad Física, Enfermedad de Alzheimer y Cognición Relativa al Genotipo APOE (PAAD-2)

19 de agosto de 2026 actualizado por: University of North Carolina, Greensboro

El efecto de la actividad física en la cognición en relación con el genotipo APOE (PAAD-2)

La actividad física y la enfermedad de Alzheimer (PAAD-2) es un ensayo de control aleatorio que evaluará los efectos del ejercicio en adultos de mediana edad (40-65 años) cognitivamente normales que tienen un mayor riesgo de enfermedad de Alzheimer (EA) debido a antecedentes familiares. (FH+). Los investigadores también evaluarán hasta qué punto este efecto es moderado por el estado de portador de la apolipoproteína épsilon-4 (APOE4), y recopilarán nueva evidencia experimental crítica sobre el uso de la actividad física para mejorar el rendimiento cognitivo de las personas con mayor riesgo de enfermedad de Alzheimer. .

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

En este estudio, los investigadores dan seguimiento a sus investigaciones anteriores que exploran los efectos de la actividad física en el rendimiento cognitivo y los mecanismos subyacentes. En particular, los investigadores están interesados ​​en los efectos potencialmente diferentes que podrían darse en función del riesgo genético de una persona para la enfermedad de Alzheimer. En este estudio, los investigadores amplían el trabajo anterior al proponer un ensayo clínico aleatorizado para: (a) probar el vínculo causal entre la actividad física y el rendimiento cognitivo en adultos de mediana edad (40-65 años) con antecedentes familiares, y (b) determinar si el efecto es moderado por el estado de portador de la apolipoproteína épsilon-4 (APOE4). Los investigadores recopilarán medidas de neuroimagen de la estructura cerebral, la integridad de la sustancia blanca y la conectividad en estado de reposo; evaluar marcadores biológicos putativos; y (utilizando análisis de mediación moderados) aumentar la comprensión de los mecanismos subyacentes y de la medida en que los efectos son moderados por el estado de portador de APOE4. Para probar las hipótesis, los investigadores asignarán al azar a 240 adultos de mediana edad cognitivamente normales a un programa de actividad física virtual de 1 año o a un control de atención habitual. Aquellos en la intervención participarán en un programa de actividad física de un año que incluye ejercicio aeróbico realizado por su cuenta y ejercicios de resistencia dirigidos en sesiones de ejercicio virtual con un instructor 1 hora/día durante 3 días/semana durante 1 año. A aquellos en la condición de control de atención habitual se les pedirá que mantengan su estilo de vida normal durante un año y luego se les otorgará una membresía de gimnasio a corto plazo (dependiendo de la finalización de las sesiones de prueba). Los investigadores evaluarán el rendimiento cognitivo antes, a la mitad y después de la prueba, y obtendrán resonancias magnéticas y muestras de sangre antes, a la mitad y después de la prueba. Los investigadores examinarán los efectos de la actividad física en el rendimiento cognitivo y en los mecanismos neurológicos y biológicos y explorarán el papel moderador de APOE4.

Tipo de estudio

Intervencionista

Inscripción (Actual)

180

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • North Carolina
      • Greensboro, North Carolina, Estados Unidos, 27402
        • University of North Carolina-Greensboro

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

40 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Descripción

Criterios de inclusión:

  • Antecedentes familiares de enfermedad de Alzheimer, deterioro cognitivo
  • Capaz de comunicarse en Inglés
  • Actualmente no cumple con las recomendaciones de actividad física (las recomendaciones son hacer ejercicio 3 días a la semana durante más de 30 minutos por día durante más de 3 meses)
  • Dispuesto a ser aleatorizado a cualquiera de las condiciones del estudio
  • Dispuesto a completar todas las actividades de estudio durante 1 año.

Criterio de exclusión:

  • Cumplir con los criterios de deterioro cognitivo clínico
  • Incapaz de realizar actividad física debido a enfermedad cardiovascular, metabólica o renal conocida y sintomática o debido a limitaciones ortopédicas
  • Historial de autoinforme de enfermedades neurológicas o médicas confusas, psiquiátricas o activas, graves o funcionalmente discapacitantes, o cualquier otra afección que pueda limitar el ejercicio o representar un peligro para el paciente
  • Uso actual de medicamentos para tratar los síntomas de la enfermedad de Alzheimer, que afectan negativamente la cognición o que afectan la frecuencia cardíaca
  • Cumplir con los criterios para la depresión utilizando la forma abreviada de la Escala de Depresión del Centro de Estudios Epidemiológicos
  • Viajar por un período prolongado (> 1 mes) durante el curso del estudio

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Condición de Actividad Física (PAC)
Se les pedirá a los sujetos que asistan a sesiones de ejercicios virtuales 3 veces por semana durante 1 año.
Conductual: Condición de actividad física
Los sujetos asistirán a sesiones de ejercicio en grupo virtuales 3 veces por semana durante 1 año. Se alentará a cada sujeto a caminar a una intensidad moderada (frecuencia cardíaca objetivo (FC) = 40-59 % de FC de reserva) en función de la FC en reposo y la edad. Los sujetos realizarán ejercicio aeróbico por su cuenta y los ejercicios de resistencia se completarán en sesiones de ejercicio virtual con un instructor 1 hora/día durante 3 días/semana durante 1 año. En las sesiones de ejercicio, se les pedirá a estos participantes que registren las medidas de los ejercicios completados y se les puede pedir que proporcionen medidas de la frecuencia cardíaca (evaluada por palpación durante 20 segundos) y la tasa de esfuerzo percibido (RPE). Se les pedirá que envíen registros de ejercicio que proporcionen esta información. Los datos de los registros de ejercicio y los registros de los especialistas en ejercicio se revisarán en busca de evidencia de progresión, logro constante de intensidad moderada y con respecto a la duración prescrita de los componentes de entrenamiento aeróbico y de fuerza.
Sin intervención: Control de Atención Habitual (UCC)
Los participantes en el control de atención habitual mantendrán sus prácticas normales de salud durante 1 año. Los participantes recibirán un boletín de salud cada dos semanas y serán contactados cada dos semanas para responder cualquier pregunta y preguntar sobre la salud del participante. La actividad física autoinformada de los participantes se evaluará mensualmente. De esta manera, el personal se pondrá en contacto con los participantes cada semana. Los participantes de control de atención habitual que completen todas las actividades relacionadas con el estudio, incluidas las pruebas previas, intermedias y posteriores, recibirán una membresía de YMCA a corto plazo después de la prueba posterior.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Performance on the Cognitive Domain of Executive Function as Measured With Stroop Interference Reaction Time (RT)
Periodo de tiempo: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in executive function will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on Stroop Interference. Stroop interference is calculated using reaction time (RT) data from correct trials and the following formula: Stroop Interference RT = Stroop Incongruent RT - (average (Stroop Congruent RT , Stroop Neutral RT)). Stroop Congruent is also known as Stroop Word, and Stroop Neutral is also known as Stroop Color. RT is recorded in msec and a larger score is indicative of greater interference (worse performance)
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Executive Function as Measured With Trail Making Test Interference
Periodo de tiempo: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in executive function will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the Comprehensive Trail Making Test (TMT) interference. TMT interference is calculated as total time to complete TMT B (also called Trail 5) minus the total time to complete TMT A (also called Trail 1)which were both recorded in seconds. TMT interference is, therefore, recorded in seconds with a larger score indicative of greater interference (worse performance)
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Executive Function as Measured With NIH Toolbox Dimensional Change Card Sort
Periodo de tiempo: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in executive function will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the NIH Toolbox Dimentional Change Card Sort Test (DCCS). We used the recommended outcome of the DCCS computed score. This is calculated automatically within the NIH Toolbox based upon a two-stage process combining a score of 0-5 from the accuracy data with a score of 0-5 from the reaction time data. Thus, scores range from 0-10 with a higher score indicative of better performance.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Executive Function as Measured With the NIH Toolbox Flanker Test.
Periodo de tiempo: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in executive function will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the NIH Toolbox Flanker Inhibitory Control and Attention Test. We used the recommended outcome of the Flanker computed score. This is calculated automatically within the NIH Toolbox based upon a two-stage process combining a score of 0-5 from the accuracy data with a score of 0-5 from the reaction time data. Thus, scores range from 0-10 with a higher score indicative of better performance.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Memory as Measured With the Auditory Verbal Learning Test.
Periodo de tiempo: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in memory will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the Auditory Verbal Learning Test. Majdan et al. (1996) Form 1 was given at pre, the standard Rey Auditory Verbal Learning list was given at mid, and Majdan et al. (1996) Form 2 was given at post. These versions are comparable in terms of their scores (Sherman, Tan, & Hrabok, 2022). Possible scores range from 0-15 with a bigger score being indicative of better memory.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Memory as Measured With the Rey-Osterrieth Complex Figure Test
Periodo de tiempo: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in memory will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the Rey Osterreith Complex Figure Test. Tests were scored using the deep learning approach for automated scoring published by Langer et al. eLife 2024;13:RP96017. DOI: https://doi.org/10.7554/eLife.96017. Possible scores range from 0-36 with higher scores being indicative of better memory.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Memory as Measured With the NIH Toolbox Picture Sequence Test
Periodo de tiempo: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in memory will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the NIH Toolbox Picture Sequence Memory Test - The computed score is an IRT-based theta score of the number of adjacent pairs placed for trial 1 and 2 with a higher score being indicative of better memory. This score is automatically created within the NIH Toolbox. Version A was given at pre, Version B was given at mid, and Version C was given at post. Possible scores range from 200-700 with a higher score being indicative of better performance.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Memory as Measured With the Mnemonic Similarity Test
Periodo de tiempo: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in memory will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) Lure Discimination Index (LDI) on the Mnemonic Similarity Test (MST). The MST was created based upon the publicly available and validated instructions and stimuli provided by the creators of the task (Stark, Kirwan, & Stark, 2019). Equivalent versions of the test are administered so participants see different stimuli at each testing session and those stimuli were counterbalanced to rotate through the different item types. The formula for calculating the LDI is: p(similar|lure) - p(similar|foil) where p(similar|lure) = Total # of "similar" responses to lure items / 36 and p(similar|foil) = Total # "similar" responses to foil items / 36. Scores range from -1 to +1 with a larger score indicating better discrimination performance.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Attention as Measured With the Paced Auditory Serial Addition Test
Periodo de tiempo: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in attention will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the 2-sec trial of the Paced Auditory Serial Addition Task. Scores are reported as the number of correct responses with possible scores ranging from 0-60 and larger scores being indicative of better attention.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Attention as Measured With the Forward Digit Span Test
Periodo de tiempo: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in attention will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the Neurological Assessment Battery (NAB) Digit Span Forward test. Scores are reported as the number of correct trials with possible scores ranging from 0-14 and larger scores being indicative of better attention.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Working Memory as Measured With NIH Toolbox List Sort Working Memory
Periodo de tiempo: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in working memory will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the NIH Toolbox List Sort Working Memory Test. Scores are reported as the sum of the total number of items correctly recalled and sequenced on Lists 1 and 2 with possible scores ranging from 0-26 and larger scores being indicative of better working memory.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Working Memory as Measured With Spatial Working Memory
Periodo de tiempo: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in working memory will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) reaction time on the 4-dot trial of the Spatial Working Memory Test. Scores are reported as the average reaction time (RT) for correct responses. Smaller scores are indicative of faster performance (i.e., better performance).
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Working Memory as Measured With Backward Digit Span
Periodo de tiempo: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in working memory will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) accuracy on the Neurological Assessment Battery (NAB) Digit Span Backwards test. Scores are reported as the number of correct trial with possible scores ranging from 0-14 and larger scores being indicative of better working memory.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Processing Speed as Measured With the Digit Symbol Modalities Test (SDMT)
Periodo de tiempo: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in working memory will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the Digit Symbol Modalities Test (SDMT) (Smith, 1973). Scores are reported as the sum of Oral and Written Trial Raw Scores (correct responses) with possible scores ranging from 0-220 and larger scores being indicative of better working memory.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Processing Speed as Measured With the Stroop Word Test
Periodo de tiempo: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in processing speed will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on Stroop Word condition (also known as the Stroop Congruent condition). RT is recorded in msec and a larger score is indicative of slower performance (worse performance)
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Processing Speed as Measured With the Stroop Color Test
Periodo de tiempo: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in processing speed will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on Stroop Color condition (also known as the Stroop Neutral condition). RT is recorded in msec and a larger score is indicative of slower performance (worse performance)
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Processing Speed as Measured With the Trail Making Test A
Periodo de tiempo: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in executive function will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on the Comprehensive Trail Making Test (TMT) A (TMT A) (also known as Trail 1). Performance is recorded in seconds with a larger score indicative of slower performance (worse performance)
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Performance on the Cognitive Domain of Executive Function as Measured With Matrix Reasoning.
Periodo de tiempo: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in executive function will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) performance on Matrix Reasoning Accuracy from the Virginia Cognitive Aging Project (VCAP). Version O was given at pre, Version A was given at mid, and Version B was given at post. Possible scores are proportions that range from 0-1 (i.e., 0% accuracy to 100% accuracy expressed on a 0.00-1.00 scale) with a higher score being indicative of better performance.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Brain Morphology (Whole Brain Volume)
Periodo de tiempo: Pre-Test and Post-Test (~12 months)
Change in whole brain morphology will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) for total segmented brain volume (i.e., total brain separated from non-brain structures). This is measured as volume (mm3), with volumes ranging from 1,050,000 to 1,350,000, and with higher values being interpreted as better.
Pre-Test and Post-Test (~12 months)
Change in Brain Morphology (Left Hippocampus Volume)
Periodo de tiempo: Pre-Test and Post-Test (~12 months)
Change in Left Hippocampus Volume will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) for total segmented left hippocampus volume (i.e., left hippocampus segmented away from other regions). This is measured as volume (mm3), ranges from 2500 to 4500, and higher values are better.
Pre-Test and Post-Test (~12 months)
Change in Brain Morphology (Right Hippocampus Volume)
Periodo de tiempo: Pre-Test and Post-Test (~12 months)
Change in Right Hippocampus Volume will be assessed by comparing Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months) for total segmented right hippocampus volume (i.e., right hippocampus segmented away from other regions). This is measured as volume (mm3), ranges from 2500 to 4500, and higher values are better.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - BDNF
Periodo de tiempo: Pre-Test and Post-Test (~12 months)
Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - Irisin
Periodo de tiempo: Pre-Test and Post-Test (~12 months)
Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - IGF-1
Periodo de tiempo: Pre-Test and Post-Test (~12 months)

Change in blood biomarkers (BDNF, irisin, IGF-1, glucose, insulin, TNF-⍺, serum amyloid protein (SAP), albumin, ApoE and ⍺-2 macroglobulin) - IGF-1. Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.

The capture antibodies in the kits we received from the company for IGF-1 were not effective. We attempted to secure new kits to conduct the assays, but did not receive the kits in a timely fashion. We intend to conduct these assays upon receipt of the kits and the availability of personnel to perform the assays. The anticipated reporting date for IGF-1 is January 2027.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - Glucose
Periodo de tiempo: Pre-Test and Post-Test (~12 months)
Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - Insulin
Periodo de tiempo: Pre-Test and Post-Test (~12 months)
Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - TNFa
Periodo de tiempo: Pre-Test and Post-Test (~12 months)
Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - SAA
Periodo de tiempo: Pre-Test and Post-Test (~12 months)
Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - ALB
Periodo de tiempo: Pre-Test and Post-Test (~12 months)
Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - ApoE
Periodo de tiempo: Pre-Test and Post-Test (~12 months)
Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.
Pre-Test and Post-Test (~12 months)
Change in Blood Biomarkers (BDNF, Irisin, IGF-1, Glucose, Insulin, TNF-⍺, Serum Amyloid Protein (SAP), Albumin, ApoE and ⍺-2 Macroglobulin) - ⍺-2 Macroglobulin
Periodo de tiempo: Pre-Test and Post-Test (~12 months)
Blood samples will be taken following a 12-hour fast. Assays will be conducted for brain-derived neurotrophic factor (BDNF), irisin, insulin-like growth factor (IGF)-1, glucose, insulin, tumor necrosis factor (TNF)-⍺, serum amyloid protein (SAP), albumin, apolipoprotein E (ApoE) and ⍺-2 macroglobulin. Change from pre-test to post-test will be assessed.
Pre-Test and Post-Test (~12 months)
Change in Cardiorespiratory Fitness
Periodo de tiempo: Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Fitness will be assessed by comparing predicted VO2max at Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months). Fitness will be assessed using a submaximal graded aerobic exercise test performed on a treadmill. Oxygen uptake (VO2) at each stage is estimated based on the treadmill speed and grade during a ramped exercise protocol performed until volitional exhaustion or test termination due to symptom limitations. The VO2max estimation uses the slope of the regression line between the heart rates (HR) of the last two stages to extrapolate to the participant's predicted VO2 at their age-predicted max HR (220-age). If HR at either of the last two stages is <110, VO2 could not be reliably calculated, and we consider the participant to have insufficient data (ID). We have explored other options for estimating VO2 max, but believe this is the best option available.
Pre-Test, Mid-Test (~6 months), and Post-Test (~12 months)
Change in Brain Activity (Resting-state Connectivity) Right Lateral Parietal, Posterior Cingulate Cortex
Periodo de tiempo: Pre-Test and Post-Test (~12 months)
Functional MRI will be used to measure brain activity including resting-state connectivity and change will be assessed from pre-test to post-test.
Pre-Test and Post-Test (~12 months)
Change in Brain Activity (Resting-state Connectivity) Left Lateral Parietal, Right Lateral Parietal
Periodo de tiempo: Pre-Test and Post-Test (~12 months)
Functional MRI will be used to measure brain activity including resting-state connectivity and change will be assessed from pre-test to post-test.
Pre-Test and Post-Test (~12 months)
Change in Brain Activity (Resting-state Connectivity) Left Lateral Parietal, Posterior Cingulate Cortex
Periodo de tiempo: Pre-Test and Post-Test (~12 months)
Functional MRI will be used to measure brain activity including resting-state connectivity and change will be assessed from pre-test to post-test.
Pre-Test and Post-Test (~12 months)
Change in Brain Activity (Resting-state Connectivity) Medial Prefrontal Cortex, Posterior Cingulate Cortex
Periodo de tiempo: Pre-Test and Post-Test (~12 months)
Functional MRI will be used to measure brain activity including resting-state connectivity and change will be assessed from pre-test to post-test.
Pre-Test and Post-Test (~12 months)
Change in Brain Activity (Resting-state Connectivity) Medial Prefrontal Cortex, Right Lateral Parietal
Periodo de tiempo: Pre-Test and Post-Test (~12 months)
Functional MRI will be used to measure brain activity including resting-state connectivity and change will be assessed from pre-test to post-test.
Pre-Test and Post-Test (~12 months)
Change in Brain Activity (Resting-state Connectivity) Medial Prefrontal Cortex, Left Lateral Parietal
Periodo de tiempo: Pre-Test and Post-Test (~12 months)
Functional MRI will be used to measure brain activity including resting-state connectivity and change will be assessed from pre-test to post-test.
Pre-Test and Post-Test (~12 months)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of North Carolina, Greensboro

Colaboradores

National Institute on Aging (NIA)
Wake Forest University Health Sciences

Investigadores

  • Investigador principal: Jennifer Etnier, PhD, UNC Greensboro

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

23 de mayo de 2019

Finalización primaria (Actual)

21 de diciembre de 2024

Finalización del estudio (Actual)

21 de diciembre de 2024

Fechas de registro del estudio

Enviado por primera vez

24 de enero de 2019

Primero enviado que cumplió con los criterios de control de calidad

12 de marzo de 2019

Publicado por primera vez (Actual)

15 de marzo de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

19 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 18-0228
  • R01AG058919 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

La documentación de datos y los datos no identificados se depositarán para compartir de conformidad con las leyes y regulaciones aplicables. Los datos estarán disponibles en un estado anónimo no identificado y en un .csv formato. Los datos se compartirán exportando los datos de RedCap a un archivo .csv archivo archivado bajo el perfil institucional del investigador principal del estudio en el repositorio institucional de Bibliotecas Universitarias de la Universidad de Carolina del Norte Greensboro (UNCG) Colección Digital en Línea de Conocimiento y Becas de Carolina del Norte (NC DOCKS).

Los datos también se compartirán a través de la Red Interactiva de la Asociación Global de Alzheimer (GAAIN), un sistema de datos federado diseñado para fomentar el intercambio de datos y el desarrollo de colaboraciones para investigadores interesados ​​en datos relacionados con el Alzheimer. Los científicos interesados ​​pueden explorar metadatos de PAAD-2 y de otros estudios. Al convertirse en socio, una descripción de PAAD-2 y un enlace para contactar al investigador principal estarán disponibles en www.gaain.org.

Marco de tiempo para compartir IPD

De acuerdo con las recomendaciones de la Colaboración para la Prevención del Alzheimer (CAP), los datos previos a la aleatorización se depositarán dentro de los 12 meses posteriores a la finalización de la inscripción. De acuerdo con las pautas de los Institutos Nacionales de Salud (NIH), los datos posteriores a la aleatorización serán embargados hasta la publicación de los principales hallazgos del estudio (es decir, aquellos hallazgos relevantes para los objetivos específicos) o dos años después del cierre del estudio (lo que ocurra primero). Las solicitudes de intercambio de datos que se presenten antes del final del período de embargo serán consideradas caso por caso por el investigador principal.

Criterios de acceso compartido de IPD

Los investigadores interesados ​​en tener acceso a los datos presentarán su solicitud a través de GAAIN y luego se les solicitará que presenten una propuesta al investigador principal. La propuesta debe incluir afiliación institucional, un currículum o vita actual, fuente de financiamiento (si corresponde) y una explicación detallada de la pregunta de investigación y los datos requeridos. Todos los solicitantes también deberán firmar un acuerdo de confidencialidad. Este acuerdo prohíbe el uso de los datos de cualquier manera que permita la identificación de participantes individuales.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • CÓDIGO_ANALÍTICO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir