Alzheimer Dementia (AD)NCT07676851
Clinical Risk Score Prediction for Risk of Dementia Among Late-life Population With Depression
An observational study of Alzheimer Dementia (AD) and Dementia, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Dementia (AD), Dementia, Late Life Depression (LLD)
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2006to 30 Jun 2030
- How long will I take part?
- 13 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Xi-jian Dai, 13755756959, daixjdoctor@126.com
About this study
Official 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
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?
Read more
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
- Being tested
- No Intervention: Observational Cohort
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline through study completion, average 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Jun 2006
- Primary completion1 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Dementia (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
- Target duration
- 13 Years
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676851
- Sponsor's protocol ID
- IIT-2024-194
- Status last verified
- May 2026
- First submitted
- 24 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No