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Fysisk aktivitet, Alzheimers sygdom og kognition i forhold til APOE-genotype (PAAD-2)

15. maj 2026 opdateret af: University of North Carolina, Greensboro

Effekten af ​​fysisk aktivitet på kognition i forhold til APOE-genotype (PAAD-2)

Fysisk aktivitet og Alzheimers sygdom (PAAD-2) er et randomiseret kontrolforsøg, der vil vurdere virkningerne af træning på midaldrende (40-65 år) kognitivt normale voksne, som har en øget risiko for Alzheimers sygdom (AD) på grund af familiehistorie (FH+). Forskerne vil også vurdere, i hvilket omfang denne effekt modereres af apolipoprotein epsilon-4 (APOE4) bærerstatus, og vil indsamle kritisk ny eksperimentel evidens for brugen af ​​fysisk aktivitet til at forbedre kognitiv ydeevne hos personer med størst risiko for Alzheimers sygdom .

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

I denne undersøgelse følger efterforskerne op på deres tidligere forskning, der undersøger virkningerne af fysisk aktivitet på kognitiv ydeevne og underliggende mekanismer. Især er efterforskerne interesserede i de potentielt forskellige effekter, der kan realiseres som en funktion af en persons genetiske risiko for Alzheimers sygdom. I denne undersøgelse udvider efterforskerne tidligere arbejde ved at foreslå et randomiseret klinisk forsøg for at: (a) teste årsagssammenhængen mellem fysisk aktivitet og kognitiv ydeevne hos midaldrende voksne (40-65 år) med en familiehistorie, og (b) bestemme, om effekten modereres af apolipoprotein epsilon-4 (APOE4) bærerstatus. Efterforskerne vil indsamle neuroimaging målinger af cerebral struktur, hvid substans integritet og hviletilstandsforbindelse; vurdere formodede biologiske markører; og (ved hjælp af modererede medieringsanalyser) øge forståelsen af ​​underliggende mekanismer og af, i hvilket omfang effekter modereres af APOE4-bærerstatus. For at teste hypoteser vil efterforskerne tilfældigt tildele 240 kognitivt normale, midaldrende voksne til et 1-årigt virtuelt fysisk aktivitetsprogram eller en sædvanlig plejekontrol. Deltagerne i interventionen vil deltage i et årelangt fysisk aktivitetsprogram, herunder aerob træning udført på egen hånd og modstandsøvelser ledet i virtuelle træningssessioner med en instruktør 1 time/dag i 3 dage/uge i 1 år. De, der er i den sædvanlige plejekontroltilstand, vil blive bedt om at opretholde deres normale livsstil i et år og vil derefter få et kortvarigt medlemskab af fitnesscenteret (afhængig af afslutning af testsessioner). Efterforskerne vil vurdere kognitiv præstation før, midt og efter test, og indhente MR-scanninger og blodprøver før, midt og efter test. Forskerne vil undersøge virkningerne af fysisk aktivitet på kognitiv ydeevne og på neurologiske og biologiske mekanismer og vil undersøge den modererende rolle af APOE4.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

180

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • North Carolina
      • Greensboro, North Carolina, Forenede Stater, 27402
        • University of North Carolina-Greensboro

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Beskrivelse

Inklusionskriterier:

  • Familiehistorie om Alzheimers sygdom, kognitiv svækkelse
  • Kan kommunikere på engelsk
  • Opfylder ikke i øjeblikket anbefalingerne for fysisk aktivitet (anbefalingerne er at træne 3 dage om ugen i 30+ minutter om dagen i mere end 3 måneder)
  • Villig til at blive randomiseret til begge undersøgelsesbetingelser
  • Villig til at gennemføre alle studieaktiviteter i 1 år

Ekskluderingskriterier:

  • Opfyld kriterierne for klinisk kognitiv svækkelse
  • Ude af stand til at udføre fysisk aktivitet på grund af kendt kardiovaskulær, metabolisk eller nyresygdom og er symptomatisk eller på grund af ortopædiske begrænsninger
  • Selvrapportering af forvirrende neurologiske, psykiatriske eller aktive alvorlige eller funktionelt invaliderende neurologiske eller medicinske sygdomme eller andre tilstande, der kan begrænse træning eller udgøre en fare for patienten
  • Nuværende brug af medicin til behandling af symptomer på Alzheimers sygdom, som påvirker kognition negativt, eller som påvirker hjertefrekvensen
  • Opfyld kriterierne for depression ved hjælp af den korte form af Center for Epidemiologiske Studier Depression Scale
  • Rejser i en længere periode (>1 måned) i løbet af studiet

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Fysisk aktivitetstilstand (PAC)
Forsøgspersoner vil blive bedt om at deltage i virtuelle træningssessioner 3 gange om ugen i 1 år.
Adfærdsmæssigt: Fysisk aktivitetstilstand
Forsøgspersoner vil deltage i virtuelle gruppeøvelser 3 gange om ugen i 1 år. Hvert forsøgsperson vil blive opfordret til at gå med en moderat intensitet (målpuls (HR) = 40-59 % HR-reserve) afhængig af hvilepuls og alder. Forsøgspersonerne vil udføre aerob træning på egen hånd, og modstandsøvelser vil blive gennemført i virtuelle træningssessioner med en instruktør 1 time/dag i 3 dage/uge i 1 år. Ved træningssessionerne vil disse deltagere blive bedt om at registrere mål for de gennemførte øvelser og kan blive bedt om at give mål for hjertefrekvens (vurderet ved palpation i 20 sekunder) og hastighed af opfattet anstrengelse (RPE). De vil blive bedt om at indsende træningslogfiler med disse oplysninger. Data fra træningslogfiler og træningsspecialistregistreringer vil blive gennemgået for tegn på progression, konsekvent opnåelse af moderat intensitet og med hensyn til den foreskrevne varighed af de aerobe og styrketræningskomponenter.
Ingen indgriben: Usual Care Control (UCC)
Deltagere i den sædvanlige plejekontrol vil opretholde deres normale helbredspraksis i 1 år. Deltagerne vil modtage et sundhedsnyhedsbrev hver anden uge og vil blive kontaktet hver anden uge for at besvare eventuelle spørgsmål og forespørge om deltagerens helbred. Deltageres selvrapporterede fysiske aktivitet vil blive vurderet månedligt. På denne måde vil deltagerne blive kontaktet af personalet hver uge. Sædvanlige plejekontroldeltagere, der gennemfører alle undersøgelsesrelaterede aktiviteter, inklusive præ-, midt- og posttest, vil modtage et kortvarigt YMCA-medlemskab efter post-test.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Performance on the Cognitive Domain of Executive Function as Measured With Stroop Interference Reaction Time (RT)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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 Executive Function as Measured With Matrix Reasoning.
Tidsramme: 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 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)
Change in Performance on the Cognitive Domain of Memory as Measured With the Auditory Verbal Learning Test.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Brain Morphology (Whole Brain Volume)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of North Carolina, Greensboro

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Jennifer Etnier, PhD, UNC Greensboro

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. maj 2019

Primær færdiggørelse (Faktiske)

21. december 2024

Studieafslutning (Faktiske)

21. december 2024

Datoer for studieregistrering

Først indsendt

24. januar 2019

Først indsendt, der opfyldte QC-kriterier

12. marts 2019

Først opslået (Faktiske)

15. marts 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 18-0228
  • R01AG058919 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Datadokumentation og afidentificerede data vil blive deponeret til deling i overensstemmelse med gældende love og regler. Data vil være tilgængelige i en afidentificeret anonym tilstand og i en .csv format. Data vil blive delt ved at eksportere data fra RedCap til en .csv fil arkiveret under studiets hovedefterforskers institutionelle profil med University of North Carolina Greensboro (UNCG) University Libraries institutionelle repository North Carolina Digital Online Collection of Knowledge and Scholarship (NC DOCKS).

Dataene vil også blive delt gennem Global Alzheimer's Association Interactive Network (GAAIN), et fødereret datasystem designet til at fremme datadeling og udvikling af samarbejder for forskere, der er interesseret i Alzheimers relaterede data. Interesserede videnskabsmænd kan udforske metadata fra PAAD-2 og fra andre undersøgelser. Ved at blive partner vil en beskrivelse af PAAD-2 og et link til at kontakte den primære investigator blive gjort tilgængelige på www.gaain.org.

IPD-delingstidsramme

I overensstemmelse med anbefalingerne fra Collaboration for Alzheimer's Prevention (CAP), vil præ-randomiseringsdata blive deponeret inden for 12 måneder efter tilmeldingens afslutning. I overensstemmelse med retningslinjerne fra National Institutes of Health (NIH) vil post-randomiseringsdata være underlagt embargo indtil offentliggørelsen af ​​hovedresultaterne af undersøgelsen (dvs. de resultater, der er relevante for de specifikke mål) eller to år efter undersøgelsens afslutning (alt efter hvad der kommer først). Anmodninger om datadeling, der kommer inden udløbet af embargoperioden, vil blive behandlet fra sag til sag af hovedefterforskeren.

IPD-delingsadgangskriterier

Efterforskere, der er interesseret i at få adgang til dataene, indsender deres anmodning gennem GAAIN og vil derefter blive bedt om at indsende et forslag til hovedefterforskeren. Forslaget bør omfatte institutionel tilknytning, et aktuelt CV eller vita, finansieringskilde (hvis relevant) og en detaljeret forklaring af forskningsspørgsmålet og de nødvendige data. Alle ansøgere skal også underskrive en aftale om fortrolighed. Denne aftale forbyder brugen af ​​dataene på nogen måde, der gør det muligt at identificere individuelle deltagere.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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