China-NINE Cohort:Neuroimmune Network in Elderly / Neurodegeneration

May 8, 2026 updated by: Maowen Ba, Yantai Yuhuangding Hospital

This is an observational study aimed at understanding the cognitive, functional, and behavioral characteristics of Chinese patients with cognitive impairment, exploring the underlying mechanisms, and providing evidence for early diagnosis, treatment, and care of cognitive disorders including dementia.

Eligible participants will undergo a series of assessments and examinations, including cognitive and memory scale tests, routine blood tests, ApoE genetic testing, cerebrospinal fluid testing, brain MRI, functional MRI, and FDG-PET/AV45-PET scans when necessary. Additional samples such as saliva, nasal secretions, and stool may also be collected. Most evaluations are provided free of charge to support diagnosis and treatment guidance.

Participation is voluntary. All personal information and research data will be kept confidential. Potential benefits include access to expert clinical care and free cognitive assessments for disease evaluation. Possible inconveniences include time commitment and temporary discomfort during examinations; medical support will be provided if needed.

Study Overview

Study Type

Observational

Enrollment (Estimated)

260

Contacts and Locations

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

Study Locations

      • Yantai, China
        • Yantai Yuhuangding Hospital
    • Shandong
      • Yantai, Shandong, China
        • Yantai Yuhuangding Hospital

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

Participants were recruited from Yantai Yuhuangding Hospital, Yantai, Shandong Province, China.

Description

Inclusion Criteria:

  • Participants with clinically diagnosed cognitive impairment. Patients with clinically diagnosed Parkinson's disease. Healthy control participants.

Exclusion Criteria:

  • Central nervous system infection, head trauma, epilepsy, multiple sclerosis, or other major neurological disorders.

Malignant tumors. Family history of genetic disorders.

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
Degree and Type of Cognitive Impairment Assessed by Neuropsychological Scales
Time Frame: From enrollment to the end of treatment at 3 years
Higher scores indicate better cognitive function; lower scores indicate more severe cognitive impairment.
From enrollment to the end of treatment at 3 years

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

January 16, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 8, 2026

First Posted (Actual)

May 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared due to privacy regulations, ethical requirements, and limitations specified in the informed consent document.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Cognitive Dysfunction

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