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NCT Number: NCT07676851

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location status: Recruiting

Location contact

Xi-jian Dai

CONTACT

[email protected]

13755756959

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No Intervention: Observational Cohort

Other

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.

Primary outcomes

  1. Incidence of Dementia

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Xi-jian Dai, PhD

CONTACT

[email protected]

13755756959

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Nanchang University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2030
Study completion
2030
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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