Alzheimer DiseaseNCT06325527
Cognitive Impairment Cohort Study of the Elderly Population in YuGarden
An observational study of Alzheimer Disease and Neurodegenerative Diseases, run by Ruijin Hospital at 1 site in China.
Trial summary
The goal of this prospective observational research with an 8-year follow-up is to study the cognitive changes in the elderly in YuGarden community, Shanghai, China. The main questions it aims to answer are: incidence of cognitive impairment in community (converting to mild cognitive impairment or Alzheimer's disease)… Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Neurodegenerative Diseases, Cognitive Impairment
- How many people
- 1,872 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Jun 2031
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population in this study includes permanent residence in YuGarden community in Shanghai with all genders and all ethnic groups aged between 60 and 85.
Who may be able to join
- The participants are community-dwelling elderly people living in Yuyuan community, Shanghai, aged 60-85 years old, with no gender restriction.
- Non-AD patients.
- The participants can complete the cognitive tests, biological sample collection, speech tests, neuroimaging examinations, and cooperate with the implementation of the whole process of research.
- The participants agree to participate in this study and sign the informed consent form.
Who cannot join
- Participants who are suffering from severe mental illness, tumor cachexia, severe liver and kidney dysfunction and other serious physical diseases and unable to cooperate with the examination.
- Participants who have visual or auditory impairment that hampers the completion of related examination.
- Situations when magnetic resonance imaging or other examinations are contraindicated.
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
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Jinwen Xiao, 13917310784, jw_xiao78@163.com
Gang Wang
About this study
Official title: Shanghai Cognitive Impairment Study of the Elderly Population: YuGarden Cohort
The goal of this prospective observational research with an 8-year follow-up is to study the cognitive changes in the elderly in YuGarden community, Shanghai, China.
The main questions it aims to answer are:
- incidence of cognitive impairment in community (converting to mild cognitive impairment or Alzheimer's disease)
- to build a predictive model for the progression of cognitive impairment
Read the detailed description
This study is a prospective observational study which involves a large sample cohort of the elderly aged 60 to 85 years in YuGarden community, Shanghai, China, with an 8-year follow-up. Demographic information, peripheral organs evaluation (facial expression, hearing, OCT angiography), cognitive tests (MMSE, ADL), biospecimen (peripheral blood, urine, feces, gingival crevicular fluid), speech information, neuroimaging (MRI, PET) and electroencephalogram (EEG) will be collected and analyzed. Follow-up visits will be conducted twice a year for 4 visits and each visit includes cognitive tests, biospecimen collection, speech test, MRI and EEG. The primary outcome is the incidence of cognitive impairment indicating people who convert to mild cognitive impairment (MCI) or Alzheimer's disease (AD). Furthermore, a predictive model for the progression of cognitive impairment will be constructed.
- Conditions
- Alzheimer Disease, Neurodegenerative Diseases, Cognitive Impairment, Mild Cognitive Impairment
- Keywords
- Alzheimer Disease, Mild Cognitive Impairment, Cohort
- Medical subject headings
- Alzheimer Disease, Neurodegenerative Diseases, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cognitive impairment
Number of participants who covert to mild cognitive impairment (MCI) or AD will be recorded to calculate the incidence.
Measured: 8 years
Secondary outcomes (13)
The change of Mini-Mental State Examination (MMSE)
MMSE is a 30-point questionnaire used to measure cognitive function (orientation, registration, attention, calculation, recall, language, repetition, complex commands). Total score ranges from 0 to 30; lower score indicates greater disease severity.
Measured: baseline, 2 year, 4 year, 6 year, 8 year
The change of Barthel Index for Activities of Daily Living (ADL)
The Barthel Index for Activities of Daily Living is an ordinal scale which measures a person's ability to complete activities of daily living (ADL). The Barthel Index measures the degree of assistance required by an individual on ten mobility and self-care ADL items. The ten items are scored with a number of points, and then a final score is calculated by summing the points awarded to each functional skill.
Measured: baseline, 2 year, 4 year, 6 year, 8 year
The change of blood biomarkers
p-tau 181, p-tau 217, pE-Aβ3-42, Aβ40, Aβ42, GFAP and NFL will be detected.
Measured: baseline, 2 year, 4 year, 6 year, 8 year
The change of urine biomarkers
The metabolomic markers in urine will be detected by mass spectrum analysis.
Measured: baseline, 2 year, 4 year, 6 year, 8 year
The change of feces biomarkers
The metabolomic markers in feces will be detected by mass spectrum analysis.
Measured: baseline, 2 year, 4 year, 6 year, 8 year
The change of gingival crevicular fluid biomarkers
The metabolomic profiles of gingival crevicular fluid will be detected by mass spectrum analysis.
Measured: baseline, 2 year, 4 year, 6 year, 8 year
The change of electroencephalogram (EEG)
Electroencephalogram (EEG) is used to measure electrical activity in the brain using small, metal discs (electrodes) attached to the scalp. Recorded frequencies include alpha, beta, delta and theta band power. The EEG signatures of people with cognitive impairment will be further analyzed, and its longitudinal changes will be observed.
Measured: baseline, 2 year, 4 year, 6 year, 8 year
The change of speech information
Voice data collection: Use a voice recorder to collect the patient's description of "stealing biscuit map" language, and save it in SWV format. And the self-developed ASR speech analysis software (China software copyright number: 2016RS164680) will be used for speech analysis.
Measured: baseline, 2 year, 4 year, 6 year, 8 year
The change of structural MRI
Structural MRI data will be acquired and analyzed through high-resolution T1-weighted MRI and diffusion tensor imaging (DTI).
Measured: baseline, 2 year, 4 year, 6 year, 8 year
The change of functional MRI
Functional MRI data will be acquired and analyzed through blood oxygenation level dependent (BOLD) imaging.
Measured: baseline, 2 year, 4 year, 6 year, 8 year
The change of magnetic susceptibility
Magnetic susceptibility data will be acquired and analyzed through quantitative susceptibility mapping (QSM).
Measured: baseline, 2 year, 4 year, 6 year, 8 year
The change of perfusion MR imaging
Perfusion imaging data will be acquired and analyzed through arterial spin labeling (ASL).
Measured: baseline, 2 year, 4 year, 6 year, 8 year
Positron emission tomography (PET)
PET including FDG-PET, Aβ-PET, Tau-PET will be used to detect brain β-amyloid and tau burden.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2031 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- 1,872 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gang Wang, MD, PhD, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325527
- Sponsor's protocol ID
- YuGarden-01
- Status last verified
- Feb 2024
- First submitted
- 26 Feb 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Cognitive Impairment Study of the Elderly Population: YuGarden Cohort
- ClinicalTrials.gov ID
- NCT06325527
- Acronym / sponsor ID
- YuGarden-01
- Conditions
- Alzheimer Disease, Neurodegenerative Diseases, Cognitive Impairment, Mild Cognitive Impairment
- Keywords
- Alzheimer Disease, Mild Cognitive Impairment, Cohort
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,872 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2031 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 22 Mar 2024 (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.
The goal of this prospective observational research with an 8-year follow-up is to study the cognitive changes in the elderly in YuGarden community, Shanghai, China.
The main questions it aims to answer are:
- incidence of cognitive impairment in community (converting to mild cognitive impairment or Alzheimer's disease)
- to build a predictive model for the progression of cognitive impairment
Detailed description
This study is a prospective observational study which involves a large sample cohort of the elderly aged 60 to 85 years in YuGarden community, Shanghai, China, with an 8-year follow-up. Demographic information, peripheral organs evaluation (facial expression, hearing, OCT angiography), cognitive tests (MMSE, ADL), biospecimen (peripheral blood, urine, feces, gingival crevicular fluid), speech information, neuroimaging (MRI, PET) and electroencephalogram (EEG) will be collected and analyzed. Follow-up visits will be conducted twice a year for 4 visits and each visit includes cognitive tests, biospecimen collection, speech test, MRI and EEG. The primary outcome is the incidence of cognitive impairment indicating people who convert to mild cognitive impairment (MCI) or Alzheimer's disease (AD). Furthermore, a predictive model for the progression of cognitive impairment will be constructed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population in this study includes permanent residence in YuGarden community in Shanghai with all genders and all ethnic groups aged between 60 and 85.
Key inclusion criteria (4 listed)
- The participants are community-dwelling elderly people living in Yuyuan community, Shanghai, aged 60-85 years old, with no gender restriction.
- Non-AD patients.
- The participants can complete the cognitive tests, biological sample collection, speech tests, neuroimaging examinations, and cooperate with the implementation of the whole process of research.
- The participants agree to participate in this study and sign the informed consent form.
Key exclusion criteria (3 listed)
- Participants who are suffering from severe mental illness, tumor cachexia, severe liver and kidney dysfunction and other serious physical diseases and unable to cooperate with the examination.
- Participants who have visual or auditory impairment that hampers the completion of related examination.
- Situations when magnetic resonance imaging or other examinations are contraindicated.
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
Incidence of cognitive impairment
Time frame: 8 years
Number of participants who covert to mild cognitive impairment (MCI) or AD will be recorded to calculate the incidence.
13 secondary outcomes
The change of Mini-Mental State Examination (MMSE)
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
The change of Barthel Index for Activities of Daily Living (ADL)
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
The change of blood biomarkers
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
The change of urine biomarkers
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
The change of feces biomarkers
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
The change of gingival crevicular fluid biomarkers
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
The change of electroencephalogram (EEG)
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
The change of speech information
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
The change of structural MRI
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
The change of functional MRI
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
The change of magnetic susceptibility
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
The change of perfusion MR imaging
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
Positron emission tomography (PET)
Time frame: baseline
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 22 Mar 2024.
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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.
Gang Wang, MD, PhD study chair
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Neurodegenerative Diseases, run by Ruijin Hospital at 1 site 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 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 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Gang Wang, MD, PhD (086-021-64370045, wg11424@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cognitive impairment (time frame: 8 years). 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 22 Mar 2024.