Cognitive DysfunctionNCT07586501
China-NINE Cohort：Neuroimmune Network in Elderly / Neurodegeneration
An observational study of Cognitive Dysfunction and Cognitive Dysfunction, Cognitive Disorder, run by Yantai Yuhuangding Hospital at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction, Cognitive Dysfunction, Cognitive Disorder, Parkinson's Disease (PD)
- How many people
- 260 participants
- Where
- 2 sitesChina
- Study dates
- 16 Jan 2026to 1 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants were recruited from Yantai Yuhuangding Hospital, Yantai, Shandong Province, China.
Who may be able to join
- Participants with clinically diagnosed cognitive impairment. Patients with clinically diagnosed Parkinson's disease. Healthy control participants.
Who cannot join
- Central nervous system infection, head trauma, epilepsy, multiple sclerosis, or other major neurological disorders.
- Malignant tumors. Family history of genetic disorders.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Yantai Yuhuangding Hospital
Yantai, Shandong
Yantai Yuhuangding Hospital
Yantai
About this study
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.
- Conditions
- Cognitive Dysfunction, Cognitive Dysfunction, Cognitive Disorder, Parkinson's Disease (PD)
- Keywords
- Cognitive impairment, dementia, Alzheimer's disease, biomarker, brain MRI, neuroimaging, cognitive assessment, elderly population, Parkinson's disease
- Medical subject headings
- Cognitive Dysfunction, Parkinson Disease, Dementia, Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree and Type of Cognitive Impairment Assessed by Neuropsychological Scales
Higher scores indicate better cognitive function; lower scores indicate more severe cognitive impairment.
Measured: From enrollment to the end of treatment at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start16 Jan 2026
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DysfunctionStudies 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
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yantai Yuhuangding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maowen Ba, Yantai Yuhuangding Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586501
- Sponsor's protocol ID
- X2026-001
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to privacy regulations, ethical requirements, and limitations specified in the informed consent document.
Publications
McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
PubMed 21514250
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China-NINE Cohort：Neuroimmune Network in Elderly / Neurodegeneration
- ClinicalTrials.gov ID
- NCT07586501
- Acronym / sponsor ID
- X2026-001
- Conditions
- Cognitive Dysfunction, Cognitive Dysfunction, Cognitive Disorder, Parkinson's Disease (PD)
- Keywords
- Cognitive impairment, dementia, Alzheimer's disease, biomarker, brain MRI, neuroimaging, cognitive assessment, elderly population, Parkinson's disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Yantai Yuhuangding HospitalUniversity, hospital or other
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were recruited from Yantai Yuhuangding Hospital, Yantai, Shandong Province, China.
Key inclusion criteria (1 listed)
- Participants with clinically diagnosed cognitive impairment. Patients with clinically diagnosed Parkinson's disease. Healthy control participants.
Key exclusion criteria (2 listed)
- Central nervous system infection, head trauma, epilepsy, multiple sclerosis, or other major neurological disorders.
- Malignant tumors. Family history of genetic disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 21514250McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
- Individual participant dataSharing planned: No. IPD will not be shared due to privacy regulations, ethical requirements, and limitations specified in the informed consent document.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Dysfunction and Cognitive Dysfunction, Cognitive Disorder, run by Yantai Yuhuangding Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree and Type of Cognitive Impairment Assessed by Neuropsychological Scales (time frame: From enrollment to the end of treatment at 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07586501, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.