Aging and Exercise Impacts on Glymphatic Function
17. august 2026 oppdatert av: Jiaen Liu, University of Texas Southwestern Medical Center
Impact of Aging and Exercise on Glymphatic Function Using Multi-modal MRI
This is a prospective, interventional, non-blinded, single center research project that will recruit cognitively unimpaired subjects in the 25-55 year old and 55-75 year old range. This study will use acute aerobic exercise as a natural intervention model to increase cardiac activity which may further drive the glymphatic function. There will be no randomization, and all enrolled subjects will participate in the exercise session.
Hypotheses: revealed by the multi-modal magnetic resonance imaging (MRI) approach, glymphatic dysfunction increases with age and is associated with preclinical Alzheimer's Disease (AD) pathology in cognitively unimpaired individuals. Using acute aerobic exercise as a human model, the enhancement of cerebrospinal fluid-interstitial fluid (CSF-ISF) exchange caused by elevated cardiac activity and paravascular cerebrospinal fluid (pCSF) dynamics can be validated.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
The purpose of this research study is to understand how the human brain removes amyloid beta (Aβ) protein which can lead to Alzheimer's disease (AD), using non-invasive magnetic resonance imaging (MRI) techniques.
Participants will first go through screening including health survey and blood draw.
Depending on their age, enrolled participants will take neuropsychological assessment, sleep and quality-of-life survey, exercise testing, MRI and positron emission tomography (PET) scans.
Depending on individual age, the study may include up to three separate visits, a blood draw, an MRI visits and a PET scan visit.
The greatest risks of this study include the possibility of injury during the exercise testing, MRI and PET scans, and loss of confidentiality.
Studietype
Intervensjonell
Registrering (Antatt)
240
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jiaen Liu, Ph.D.
- Telefonnummer: 612/423-8380
- E-post: Jiaen.Liu@UTSouthwestern.edu
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
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- age 25-75 years old
- cognitively unimpaired (CU)
- Mini-Mental State Examination (MMSE) score ≥27 at enrollment screening
- matched gender
- all racial/ethnic groups
Exclusion Criteria:
- pregnant women
- history of stroke or other major cerebrovascular disease;
- diagnosis of Alzheimer's disease (AD) or other types of dementia;
- diagnosis of major neurologic and psychiatric disorders (e.g., Parkingson's disease, major depression);
- history of prior head trauma, significant autoimmune disorders,
- sleep apnea;
- major systemic illness likely to affect the central nervous system, e.g., uncontrolled diabetes, severe cardiovascular disease, cancer, etc.;
- prior or current alcoholism or drug abuse;
- resistant hypertension (SBP ≥140 or DBP ≥ 90 mmHg despite 3 antihypertensive drugs at maximal doses);
- orthostatic hypotension defined as the third standing systolic blood pressure (SBP) < 100mmHg; any contraindications to having a MRI, e.g., claustrophobia, pacemaker or other medical device of metal;
- any conditions judged by the investigators to be medically inappropriate, risky or likely to cause poor study compliance.
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: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Acute aerobic exercise- Interventional Group
This group will include all enrolled participants from all age groups, will receive MRI scans for glymphatic function and participate in acute aerobic exercise (intervention) between MRI sessions.
They may / may not undergo PET scans.
|
During the MRI session, subject will perform aerobic exercise on a MR-compatible ergometer and will be guided to reach certain heart rate level depending on subject's age.
Their vital signs will be closely monitored by the research team to ensure safety.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Exercise-induced changes in heart rate (HR)
Tidsramme: Baseline (pre-exercise), immediately post-exercise
|
During exercise, HR will be continuously monitored using photoplethysmography (ppg) by a device attached to a finger of the subjects.
|
Baseline (pre-exercise), immediately post-exercise
|
|
Exercise-induced changes in cardiac output (CO)
Tidsramme: Baseline (pre-exercise), immediately post-exercise
|
During exercise, CO will be calculated based on HR and real time blood pressure (BP) acquired on the index finger using an MRI-compatible device.
|
Baseline (pre-exercise), immediately post-exercise
|
|
Exercise-induced changes in MRI measurements of pCSF dynamics
Tidsramme: Baseline (pre-exercise), immediately post-exercise
|
pCSF will be assessed using MRI in the brain.
|
Baseline (pre-exercise), immediately post-exercise
|
|
Exercise-induced changes in MRI measurements of CSF-ISF exchange
Tidsramme: Baseline (pre-exercise), immediately post-exercise
|
CSF-ISF exchange will be assessed using MRI in the brain.
|
Baseline (pre-exercise), immediately post-exercise
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jiaen Liu, Ph.D., University of Texas Southwestern Medical Center
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 (Antatt)
1. desember 2026
Primær fullføring (Antatt)
1. desember 2029
Studiet fullført (Antatt)
1. desember 2029
Datoer for studieregistrering
Først innsendt
12. august 2026
Først innsendt som oppfylte QC-kriteriene
17. august 2026
Først lagt ut (Faktiske)
20. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STU20260916
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Individual participant data that underlie the results reported in publication, after deidentification (text, tables, figures, and appendices).
IPD-delingstidsramme
Between the time range beginning 3 months and ending 5 years following publication.
Tilgangskriterier for IPD-deling
Researchers who provide a methodologically sound proposal.
Proposals should be directed to Jiaen.Liu@UTSouthwestern.edu.
To gain access, data requestors will need to sign a data access agreement.
Data are available for 5 years at NIH's data repository.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
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. .