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RecruitingNCT07676851Updated Jun 30, 2026

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

An observational study in Alzheimer Dementia (AD), Dementia and Late Life Depression (LLD), sponsored by Second Affiliated Hospital of Nanchang University. Recruiting at 1 site in China. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Second Affiliated Hospital of Nanchang University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
44
Ages
50 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Alzheimer Dementia (AD)
  • Dementia
  • Late Life Depression (LLD)
  • Risk Scores
  • Prediction
  • Chinese Population
  • Obs e r
  • Observational Cohort Study
  • External Validation
03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
44 participants (estimated)
Target follow-up
13 Years
Patient registry
Yes

Groups and cohorts

  • 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.

    Other: No Intervention: Observational Cohort

  • 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.

    Other: No Intervention: Observational Cohort

Interventions

  • OtherNo Intervention: Observational Cohort

    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.

05

What researchers measure

Primary outcomes

  1. Incidence of Dementia

    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).

    Time frame: Baseline through study completion, average 10 years

06

Study locations

1 of 1 sites recruiting
  • Second Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi 330006, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07676851
Lead sponsor
Second Affiliated Hospital of Nanchang University
Responsible party
Sponsor
First posted
Jun 30, 2026
Start date
Jun 1, 2006
Primary completion
Jun 1, 2030 (estimated)
Completion
Jun 30, 2030 (estimated)
Last update
Jun 30, 2026

Study contacts

Xi-jian Dai, PhD
Contact
daixjdoctor@126.com
13755756959

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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