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Clinical Risk Score Prediction for Risk of Dementia Among Late-life Population With Depression

Development of a Clinical Risk Score Prediction Tool for 5-, 9-, and 13-year Risk of Dementia Among Late-life Population With Depression: a Longitudinal Cohort Study

The goal of this observational study is to learn about the ability of a point risk score prediction model, developed using electronic medical record data, to predict the risk of progression from geriatric depression to dementia in older Chinese adults. The main questions it aims to answer are:

Does a higher point risk score increase the risk of developing dementia in older adults with depression?

What is the accuracy of the point risk score prediction model in identifying individuals at high risk of dementia among older adults with depression?

Participants will receive their usual medical care as they normally would. No new treatments, tests, or procedures will be performed specifically for this study. The research team will collect data from their electronic medical records, including depression diagnoses, dementia diagnoses, comorbidities, medication records, and follow-up information. The point risk score will be calculated based on these routinely collected clinical data.

Studieoversikt

Studietype

Observasjonsmessig

Registrering (Antatt)

44

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

    • Jiangxi
      • Nanchang, Jiangxi, Kina, 330006
        • Rekruttering
        • Second Affiliated Hospital of Nanchang University
        • Ta kontakt med:

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

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The study population consists of older adults aged ≥50 years with a baseline diagnosis of depression, derived from a prospective cohort at the data center of the Second Affiliated Hospital of Nanchang University, China (2010-2025). All participants are patients receiving routine clinical care at the hospital. Data are prospectively collected through the hospital's electronic medical record system, including demographic information, clinical laboratory indicators, depression records, and incident dementia diagnoses during follow-up, to identify preclinical risk factors for progression from geriatric depression to dementia and to develop a point risk score prediction model.

Beskrivelse

Inclusion Criteria:

  • Adults aged ≥50 years.
  • A diagnosis of depression clearly recorded by a clinician in the electronic medical record at baseline (based on structured or unstructured diagnostic documentation formed through routine clinical practice).
  • Complete baseline electronic medical record data available, including at least demographic information (age, sex), clinical diagnoses, comorbidities, and medication records.
  • At least one follow-up record available in the electronic medical record system to enable determination of incident dementia outcomes.
  • Informed consent provided for the use of routine medical data for this research analysis.

Exclusion Criteria:

  • Any type of dementia diagnosis recorded in the electronic medical record at baseline (including Alzheimer's disease, vascular dementia, and other types of dementia).
  • Medical record documentation indicating that the diagnosis of dementia preceded the diagnosis of depression, or an inability to clearly determine the chronological order of the two diagnoses.
  • Presence of other neurological diseases at baseline that may independently cause severe cognitive impairment (e.g., Parkinson's disease, multiple sclerosis, brain tumor, normal pressure hydrocephalus).
  • Missing key baseline electronic medical record data that would preclude subsequent risk model analysis.
  • Incomplete follow-up information or inability to clearly confirm incident dementia outcomes through the electronic medical record system.
  • Refusal to participate in the study or withdrawal of informed consent.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Dementia Group
Participants who received a first diagnosis of dementia during the follow-up period. No study-specific intervention is administered; all participants receive routine clinical care as usual.
This is an observational study with no study-specific intervention. All participants receive their routine standard medical care as usual. No new drugs, devices, procedures, or behavioral modifications are assigned as part of this research.
Non-Dementia Group
Participants with no diagnosis of dementia during the follow-up period. No study-specific intervention is administered; all participants receive routine clinical care as usual.
This is an observational study with no study-specific intervention. All participants receive their routine standard medical care as usual. No new drugs, devices, procedures, or behavioral modifications are assigned as part of this research.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Dementia
Tidsramme: Baseline through study completion, average 10 years
New-onset dementia in older adults with depression, defined by clinician-recorded dementia diagnosis in electronic medical records (including Alzheimer's disease, vascular dementia, and other types of dementia).
Baseline through study completion, average 10 years

Samarbeidspartnere og etterforskere

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

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)

1. juni 2006

Primær fullføring (Antatt)

1. juni 2030

Studiet fullført (Antatt)

30. juni 2030

Datoer for studieregistrering

Først innsendt

24. juni 2026

Først innsendt som oppfylte QC-kriteriene

24. juni 2026

Først lagt ut (Faktiske)

30. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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. .

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