Cohort Study on Cognitive Decline in Elderly

July 22, 2025 updated by: Peking University Third Hospital

Alzheimer's Disease (AD) prevention and control currently face severe challenges, with limited treatment options and effectiveness available. Once the disease progresses to the AD stage, it is essentially irreversible. Before the onset of AD, there is a prolonged asymptomatic period and a stage of mild cognitive impairment (MCI), which represents a critical window for early screening, diagnosis, and intervention. Therefore, early screening, diagnosis, and intervention during the MCI stage are crucial for slowing or halting the rising trend of AD and alleviating its disease burden.

This study plans to enroll elderly individuals from communities around Peking University Third Hospital to establish a prospective cohort. Participants will undergo cognitive assessments and blood biomarker testing, followed by a three-year follow-up and management program. The study aims to obtain epidemiological data on MCI and AD in community populations, investigate the relationships between known risk factors, genetic factors, and blood biomarkers with disease progression, explore additional biomarkers, and develop predictive models. These efforts will contribute to promoting early diagnosis, early intervention, and improved prognosis.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This study will enroll elderly individuals meeting the inclusion/exclusion criteria from communities surrounding Peking University Third Hospital.

Description

Inclusion Criteria:

  1. Aged 55 years or older;
  2. No diagnosis of Alzheimer's disease (AD);
  3. Participants are able to complete cognitive tests, provide biological samples, undergo neuroimaging examinations, and cooperate throughout the entire study process;
  4. Signed informed consent.

Exclusion Criteria:

  1. Participants with severe mental illness, tumor-related cachexia, severe hepatic or renal insufficiency, or other major physical conditions that may hinder cooperation with the examinations;
  2. Participants who are unable to complete the required assessments due to visual or hearing impairments;
  3. Contraindications for MRI or other study-related examinations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of MMSE
Time Frame: 3 years
MMSE is a 30-point questionnaire used to measure cognitive function
3 years
The change of MoCA
Time Frame: 3 years
MoCA is a 30-point questionnaire used to measure cognitive function
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Qiong Yang, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

July 22, 2025

First Submitted That Met QC Criteria

July 22, 2025

First Posted (Actual)

July 30, 2025

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 22, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M20250361

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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