Alzheimer's Disease，Mild Cognitive ImpairmentNCT07093892
Cohort Study on Cognitive Decline in Elderly
An observational study of Alzheimer's Disease，Mild Cognitive Impairment, run by Peking University Third Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease，Mild Cognitive Impairment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Dec 2028
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will enroll elderly individuals meeting the inclusion/exclusion criteria from communities surrounding Peking University Third Hospital.
Who may be able to join
- Aged 55 years or older;
- No diagnosis of Alzheimer's disease (AD);
- Participants are able to complete cognitive tests, provide biological samples, undergo neuroimaging examinations, and cooperate throughout the entire study process;
- Signed informed consent.
Who cannot join
- 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;
- Participants who are unable to complete the required assessments due to visual or hearing impairments;
- Contraindications for MRI or other study-related examinations.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of MMSE
MMSE is a 30-point questionnaire used to measure cognitive function
Measured: 3 years
The change of MoCA
MoCA is a 30-point questionnaire used to measure cognitive function
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease，Mild Cognitive ImpairmentStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiong Yang, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093892
- Sponsor's protocol ID
- M20250361
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study on Cognitive Decline in Elderly
- ClinicalTrials.gov ID
- NCT07093892
- Acronym / sponsor ID
- M20250361
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 Jul 2025 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll elderly individuals meeting the inclusion/exclusion criteria from communities surrounding Peking University Third Hospital.
Key inclusion criteria (4 listed)
- Aged 55 years or older;
- No diagnosis of Alzheimer's disease (AD);
- Participants are able to complete cognitive tests, provide biological samples, undergo neuroimaging examinations, and cooperate throughout the entire study process;
- Signed informed consent.
Key exclusion criteria (3 listed)
- 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;
- Participants who are unable to complete the required assessments due to visual or hearing impairments;
- Contraindications for MRI or other study-related examinations.
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
The change of MMSE
Time frame: 3 years
MMSE is a 30-point questionnaire used to measure cognitive function
The change of MoCA
Time frame: 3 years
MoCA is a 30-point questionnaire used to measure cognitive function
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 30 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Qiong Yang principal investigator
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease，Mild Cognitive Impairment, run by Peking University Third Hospital.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Qiong Yang (+861082265024, yangqiongputh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of MMSE (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2025.