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Fysisk aktivitet, Alzheimers sykdom og kognisjon i forhold til APOE-genotype (PAAD-2)

19. august 2026 oppdatert av: University of North Carolina, Greensboro

Effekten av fysisk aktivitet på kognisjon i forhold til APOE-genotype (PAAD-2)

Fysisk aktivitet og Alzheimers sykdom (PAAD-2) er en randomisert kontrollstudie som vil vurdere effekten av trening på middelaldrende (40-65 år) kognitivt normale voksne som har økt risiko for Alzheimers sykdom (AD) på grunn av familiehistorie (FH+). Etterforskerne vil også vurdere i hvilken grad denne effekten modereres av apolipoprotein epsilon-4 (APOE4) bærerstatus, og vil samle kritiske nye eksperimentelle bevis på bruk av fysisk aktivitet for å forbedre kognitiv ytelse hos personer med størst risiko for Alzheimers sykdom .

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

I denne studien følger etterforskerne opp sin tidligere forskning som utforsker effekten av fysisk aktivitet på kognitiv ytelse og underliggende mekanismer. Spesielt er etterforskerne interessert i de potensielt forskjellige effektene som kan realiseres som en funksjon av en persons genetiske risiko for Alzheimers sykdom. I denne studien utvider etterforskerne tidligere arbeid ved å foreslå en randomisert klinisk studie for å: (a) teste årsakssammenhengen mellom fysisk aktivitet og kognitiv ytelse hos middelaldrende voksne (40-65 år) med en familiehistorie, og (b) avgjøre om effekten modereres av apolipoprotein epsilon-4 (APOE4) bærerstatus. Etterforskerne vil samle nevroimaging mål av cerebral struktur, hvit substans integritet, og hviletilstand tilkobling; vurdere antatte biologiske markører; og (ved hjelp av modererte medieringsanalyser) øke forståelsen av underliggende mekanismer og av i hvilken grad effekter modereres av APOE4-bærerstatus. For å teste hypoteser, vil etterforskerne tilfeldig tildele 240 kognitivt normale, middelaldrende voksne til et 1-årig virtuelt fysisk aktivitetsprogram eller en vanlig omsorgskontroll. De som deltar i intervensjonen vil delta i et årslangt fysisk aktivitetsprogram inkludert aerobic trening utført på egen hånd og motstandsøvelser ledet i virtuelle treningsøkter med en instruktør 1 time/dag i 3 dager/uke i 1 år. De som er i den vanlige pleiekontrolltilstanden vil bli bedt om å opprettholde sin normale livsstil i ett år og vil deretter bli gitt et kortvarig medlemskap i treningssenteret (avhengig av fullføring av testøkter). Etterforskerne vil vurdere kognitiv ytelse ved pre-, mid- og post-test, og innhente MR-skanninger og blodprøver ved pre-, mid- og post-test. Etterforskerne vil undersøke effekten av fysisk aktivitet på kognitiv ytelse og på nevrologiske og biologiske mekanismer og vil utforske den modererende rollen til APOE4.

Studietype

Intervensjonell

Registrering (Faktiske)

180

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • North Carolina
      • Greensboro, North Carolina, Forente stater, 27402
        • University of North Carolina-Greensboro

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Beskrivelse

Inklusjonskriterier:

  • Familiehistorie med Alzheimers sykdom, kognitiv svikt
  • Kunne kommunisere på engelsk
  • Oppfyller ikke anbefalingene for fysisk aktivitet for øyeblikket (anbefalingene er å trene 3 dager/uke i 30+ minutter per dag i mer enn 3 måneder)
  • Villig til å bli randomisert til begge studietilstandene
  • Villig til å gjennomføre alle studieaktiviteter i 1 år

Ekskluderingskriterier:

  • Oppfyll kriteriene for klinisk kognitiv svikt
  • Kan ikke utføre fysisk aktivitet på grunn av kjent kardiovaskulær, metabolsk eller nyresykdom og er symptomatisk eller på grunn av ortopediske begrensninger
  • Selvrapportering av forvirrende nevrologiske, psykiatriske eller aktive alvorlige eller funksjonelt invalidiserende nevrologiske eller medisinske sykdommer, eller andre forhold som kan begrense trening eller utgjøre en fare for pasienten
  • Nåværende bruk av medisiner for å behandle symptomer på Alzheimers sykdom, som påvirker kognisjon negativt, eller som påvirker hjertefrekvensen
  • Oppfyll kriteriene for depresjon ved å bruke den korte formen til Center for Epidemiological Studies Depression Scale
  • Reiser over en lengre periode (>1 måned) i løpet av studiet

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Fysisk aktivitetstilstand (PAC)
Fagene vil bli bedt om å delta på virtuelle treningsøkter 3 ganger i uken i 1 år.
Atferdsmessig: Fysisk aktivitetstilstand
Fagene vil delta på virtuelle gruppeøvelser 3 ganger i uken i 1 år. Hvert forsøksperson vil bli oppfordret til å gå med moderat intensitet (målpuls (HR) = 40-59 % HR-reserve) avhengig av hvilepuls og alder. Fagene vil utføre aerobic trening på egenhånd og motstandsøvelser vil bli gjennomført i virtuelle treningsøkter med instruktør 1 time/dag i 3 dager/uke i 1 år. På treningsøktene vil disse deltakerne bli bedt om å registrere mål på øvelsene som er fullført, og kan bli bedt om å gi mål på hjertefrekvens (vurdert ved palpasjon i 20 sekunder) og hastighet på opplevd anstrengelse (RPE). De vil bli bedt om å sende inn treningslogger som gir denne informasjonen. Data fra treningslogger og treningsspesialister vil bli gjennomgått for bevis på progresjon, konsekvent oppnåelse av moderat intensitet, og med hensyn til den foreskrevne varigheten av aerobic- og styrketreningskomponentene.
Ingen inngripen: Vanlig omsorgskontroll (UCC)
Deltakere i den vanlige omsorgskontrollen vil opprettholde sin normale helsepraksis i 1 år. Deltakerne vil motta et helsenyhetsbrev annenhver uke og vil bli kontaktet annenhver uke for å svare på eventuelle spørsmål og spørre om deltakerens helse. Deltakernes egenrapporterte fysiske aktivitet vil bli vurdert månedlig. På denne måten vil deltakerne bli kontaktet av personalet hver uke. Vanlige omsorgskontrolldeltakere som fullfører alle studierelaterte aktiviteter inkludert før-, midt- og ettertest vil motta et kortvarig YMCA-medlemskap etter posttest.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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 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)
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 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of North Carolina, Greensboro

Samarbeidspartnere

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

Etterforskere

  • Hovedetterforsker: Jennifer Etnier, PhD, UNC Greensboro

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

23. mai 2019

Primær fullføring (Faktiske)

21. desember 2024

Studiet fullført (Faktiske)

21. desember 2024

Datoer for studieregistrering

Først innsendt

24. januar 2019

Først innsendt som oppfylte QC-kriteriene

12. mars 2019

Først lagt ut (Faktiske)

15. mars 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Datadokumentasjon og avidentifiserte data vil bli deponert for deling i samsvar med gjeldende lover og forskrifter. Data vil være tilgjengelig i en avidentifisert anonym tilstand og i en .csv format. Data vil bli delt ved å eksportere dataene fra RedCap til en .csv fil arkivert under studiens hovedetterforskers institusjonelle profil med University of North Carolina Greensboro (UNCG) University Libraries institusjonelle repository North Carolina Digital Online Collection of Knowledge and Scholarship (NC DOCKS).

Dataene vil også bli delt gjennom Global Alzheimer's Association Interactive Network (GAAIN), et forent datasystem designet for å fremme datadeling og utvikling av samarbeid for forskere som er interessert i Alzheimers relaterte data. Interesserte forskere kan utforske metadata fra PAAD-2 og fra andre studier. Ved å bli partner vil en beskrivelse av PAAD-2 og lenke til kontakt med hovedetterforskeren gjøres tilgjengelig på www.gaain.org.

IPD-delingstidsramme

I samsvar med anbefalingene fra Collaboration for Alzheimer's Prevention (CAP), vil pre-randomiseringsdata bli deponert innen 12 måneder etter at registreringen er fullført. I samsvar med retningslinjene fra National Institutes of Health (NIH), vil post-randomiseringsdata bli underlagt embargo frem til publisering av hovedfunnene fra studien (dvs. disse funnene som er relevante for de spesifikke målene) eller to år etter studieavslutning (avhengig av hva som kommer først). Forespørsler om datadeling som kommer før slutten av embargoperioden vil bli vurdert fra sak til sak av hovedetterforskeren.

Tilgangskriterier for IPD-deling

Etterforskere som er interessert i å ha tilgang til dataene vil sende inn forespørselen sin gjennom GAAIN og deretter bli bedt om å sende inn et forslag til hovedetterforskeren. Forslaget bør inkludere institusjonell tilknytning, en nåværende CV eller vita, finansieringskilde (hvis aktuelt), og en detaljert forklaring av forskningsspørsmålet og dataene som kreves. Alle søkere vil også bli pålagt å signere en avtale om konfidensialitet. Denne avtalen forbyr bruk av dataene på noen måte som gjør det mulig å identifisere individuelle deltakere.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere