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

NCT07676851 | Recruiting DMC

• 1 other identifier: IIT-2024-194
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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).

  Baseline through study completion, average 10 years

Study Arms (2)

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

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.

Dementia Group; Non-Dementia Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Xi-jian Dai, PhD

CONTACT

13755756959; daixjdoctor@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 13 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: June 1, 2006
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: June 30, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)