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.

Study Overview

• Status: Recruiting
• Conditions: Dementia; Late Life Depression (LLD); Alzheimer Dementia (AD); Prediction; External Validation; Risk Scores; Chinese Population; Observational Cohort Study; Obs e r
• Intervention / Treatment: Other: No Intervention: Observational Cohort

• Study Type: Observational
• Enrollment (Estimated): 44

Contacts and Locations

• Study Contact: Name: Xi-jian Dai, PhD; Phone Number: 13755756959; Email: daixjdoctor@126.com

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • Second Affiliated Hospital of Nanchang University
      • Contact: Xi-jian Dai; Phone Number: 13755756959; Email: daixjdoctor@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Other: No 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline through study completion, average 10 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2006
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Dementia
• Other Study ID Numbers: IIT-2024-194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No