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Atividade física, doença de Alzheimer e cognição em relação ao genótipo APOE (PAAD-2)

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

O efeito da atividade física na cognição em relação ao genótipo APOE (PAAD-2)

A atividade física e a doença de Alzheimer (PAAD-2) é um estudo de controle randomizado que avaliará os efeitos do exercício em adultos cognitivamente normais de meia-idade (40-65 anos) que apresentam um risco aumentado de doença de Alzheimer (DA) devido ao histórico familiar (FH+). Os pesquisadores também avaliarão até que ponto esse efeito é moderado pelo status de portador da apolipoproteína epsilon-4 (APOE4) e reunirão novas evidências experimentais críticas sobre o uso de atividade física para melhorar o desempenho cognitivo por pessoas com maior risco de doença de Alzheimer. .

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Neste estudo, os pesquisadores dão continuidade às suas pesquisas anteriores explorando os efeitos da atividade física no desempenho cognitivo e nos mecanismos subjacentes. Em particular, os investigadores estão interessados ​​nos efeitos potencialmente diferentes que podem ocorrer em função do risco genético de uma pessoa para a doença de Alzheimer. Neste estudo, os pesquisadores estendem o trabalho anterior propondo um ensaio clínico randomizado para: (a) testar a relação causal entre atividade física e desempenho cognitivo em adultos de meia-idade (40-65 anos) com histórico familiar e (b) determine se o efeito é moderado pelo status de portador da apolipoproteína epsilon-4 (APOE4). Os investigadores coletarão medidas de neuroimagem da estrutura cerebral, integridade da substância branca e conectividade do estado de repouso; avaliar marcadores biológicos putativos; e (usando análises de mediação moderada) aumentar a compreensão dos mecanismos subjacentes e da medida em que os efeitos são moderados pelo status de portador de APOE4. Para testar as hipóteses, os investigadores designarão aleatoriamente 240 adultos de meia-idade cognitivamente normais para um programa de atividade física virtual de 1 ano ou um controle de cuidados habituais. Os participantes da intervenção participarão de um programa de atividade física de um ano, incluindo exercícios aeróbicos realizados por conta própria e exercícios de resistência conduzidos em sessões de exercícios virtuais com um instrutor 1 hora/dia durante 3 dias/semana durante 1 ano. Aqueles na condição de controle de cuidados habituais serão solicitados a manter seu estilo de vida normal por um ano e, em seguida, receberão uma associação de academia de ginástica de curto prazo (contingente após a conclusão das sessões de teste). Os investigadores avaliarão o desempenho cognitivo no pré, no meio e no pós-teste e obterão exames de ressonância magnética e amostras de sangue no pré, no meio e no pós-teste. Os investigadores examinarão os efeitos da atividade física no desempenho cognitivo e nos mecanismos neurológicos e biológicos e explorarão o papel moderador da APOE4.

Tipo de estudo

Intervencional

Inscrição (Real)

180

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

40 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Descrição

Critério de inclusão:

  • Histórico familiar de doença de Alzheimer, comprometimento cognitivo
  • Capaz de se comunicar em inglês
  • Atualmente não atende às recomendações para atividade física (as recomendações são para se exercitar 3 dias/semana por mais de 30 minutos por dia por mais de 3 meses)
  • Disposto a ser randomizado para qualquer condição de estudo
  • Disposto a concluir todas as atividades de estudo por 1 ano

Critério de exclusão:

  • Atende aos critérios para comprometimento cognitivo clínico
  • Incapaz de realizar atividade física devido a doença cardiovascular, metabólica ou renal conhecida e sintomático ou devido a limitações ortopédicas
  • Histórico de auto-relato de confusão neurológica, psiquiátrica ou doenças neurológicas ou médicas severas ou funcionalmente incapacitantes, ou quaisquer outras condições que possam limitar o exercício ou representar um perigo para o paciente
  • Uso atual de medicamentos para tratar sintomas da doença de Alzheimer, que afetam adversamente a cognição ou que afetam a frequência cardíaca
  • Atender aos critérios para depressão usando a forma abreviada da Escala de Depressão do Centro de Estudos Epidemiológicos
  • Viajar por um período prolongado (> 1 mês) durante o curso do estudo

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Condição de Atividade Física (PAC)
Os indivíduos serão convidados a participar de sessões de exercícios virtuais 3 vezes por semana durante 1 ano.
Comportamental: Condição de Atividade Física
Os participantes participarão de sessões de exercícios em grupo virtual 3x/semana durante 1 ano. Cada sujeito será encorajado a caminhar em intensidade moderada (frequência cardíaca alvo (FC) = 40-59% FC de reserva), dependendo da FC em repouso e da idade. Os indivíduos realizarão exercícios aeróbicos por conta própria e os exercícios de resistência serão concluídos em sessões de exercícios virtuais com um instrutor 1 hora/dia durante 3 dias/semana durante 1 ano. Nas sessões de exercícios, esses participantes serão solicitados a registrar medidas dos exercícios realizados e podem ser solicitados a fornecer medidas de frequência cardíaca (avaliada por palpação por 20 segundos) e taxa de esforço percebido (RPE). Eles serão solicitados a enviar registros de exercícios fornecendo essas informações. Os dados dos registros de exercícios e registros de especialistas em exercícios serão revisados ​​quanto à evidência de progressão, obtenção consistente de intensidade moderada e com relação à duração prescrita dos componentes de treinamento aeróbico e de força.
Sem intervenção: Controle de Cuidados Habituais (UCC)
Os participantes do controle de cuidados habituais manterão suas práticas normais de saúde por 1 ano. Os participantes receberão um boletim de saúde quinzenal e serão contatados quinzenalmente para responder a quaisquer perguntas e indagar sobre a saúde do participante. A atividade física autorreferida pelos participantes será avaliada mensalmente. Dessa forma, os participantes serão contatados semanalmente pela equipe. Os participantes do controle de cuidados habituais que concluírem todas as atividades relacionadas ao estudo, incluindo pré, intermediário e pós-teste, receberão uma associação YMCA de curto prazo após o pós-teste.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Performance on the Cognitive Domain of Executive Function as Measured With Stroop Interference Reaction Time (RT)
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Brain Morphology (Whole Brain Volume)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

23 de maio de 2019

Conclusão Primária (Real)

21 de dezembro de 2024

Conclusão do estudo (Real)

21 de dezembro de 2024

Datas de inscrição no estudo

Enviado pela primeira vez

24 de janeiro de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de março de 2019

Primeira postagem (Real)

15 de março de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 18-0228
  • R01AG058919 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

A documentação de dados e dados não identificados serão depositados para compartilhamento de acordo com as leis e regulamentos aplicáveis. Os dados estarão disponíveis em um estado anônimo não identificado e em um arquivo .csv formatar. Os dados serão compartilhados exportando os dados do RedCap para um arquivo .csv arquivo arquivado no perfil institucional do investigador principal do estudo no repositório institucional das Bibliotecas da Universidade de Greensboro (UNCG) da Universidade da Carolina do Norte Coleção digital on-line de conhecimento e bolsa de estudos da Carolina do Norte (NC DOCKS).

Os dados também serão compartilhados por meio da Rede Interativa da Associação Global de Alzheimer (GAAIN), um sistema de dados federado projetado para promover o compartilhamento de dados e o desenvolvimento de colaborações para pesquisadores interessados ​​em dados relacionados ao Alzheimer. Cientistas interessados ​​podem explorar os metadados do PAAD-2 e de outros estudos. Ao se tornar um parceiro, uma descrição do PAAD-2 e um link para contato com o pesquisador principal serão disponibilizados em www.gaain.org.

Prazo de Compartilhamento de IPD

De acordo com as recomendações da Collaboration for Alzheimer's Prevention (CAP), os dados de pré-randomização serão depositados dentro de 12 meses após a conclusão da inscrição. De acordo com as diretrizes do National Institutes of Health (NIH), os dados pós-randomização serão embargados até a publicação das principais descobertas do estudo (ou seja, os resultados relevantes para os objetivos específicos) ou dois anos após o encerramento do estudo (o que ocorrer primeiro). As solicitações de compartilhamento de dados que ocorrerem antes do final do período de embargo serão consideradas caso a caso pelo investigador principal.

Critérios de acesso de compartilhamento IPD

Os investigadores interessados ​​em ter acesso aos dados apresentarão o seu pedido através do GAAIN e depois serão convidados a apresentar uma proposta ao investigador principal. A proposta deve incluir afiliação institucional, um currículo atual ou vita, fonte de financiamento (se aplicável) e uma explicação detalhada da questão da pesquisa e dos dados necessários. Todos os candidatos também serão obrigados a assinar um acordo de confidencialidade. Este acordo proíbe o uso dos dados de qualquer forma que permita a identificação de participantes individuais.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF
  • ANALYTIC_CODE

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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