Alzheimer DiseaseSheMountainNCT05667935
Cognitive Impairment Cohort Study of the Elderly Population in SheMountain
An observational study of Alzheimer Disease and Dementia, run by Ruijin Hospital at 1 site in China.
Trial summary
This study is a prospective observational study, which involves a cohort of 2000 all-sex and all-ethnic people aged 60 years and above with permanent residence in Tianma area, SheMountain Town, Songjiang District (suburban area), Shanghai. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia, Neurodegenerative Diseases
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2022to 31 Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population in this study includes permanent residence in SheMountain Town, Songjiang District (suburbs), Shanghai with all genders and all ethnic groups aged 60 and above.
Who may be able to join
- All genders and all ethnic groups aged 60 and above with permanent residence in Tianma area, SheMountain Town, Songjiang District (suburbs), Shanghai.
- Agree to collect neuropsychiatric scales, biological samples, imaging and other examination information.
- Agree to participate in this study and sign the informed consent form. And promise to abide by the research procedures, and cooperate with the implementation of the whole process of research
Who cannot join
- Suffering from severe mental illness, tumor cachexia, severe liver and kidney dysfunction and other serious physical diseases and unable to cooperate
- Uncorrectable visual or auditory impairment that hampers the completion of related examination.
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 Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Jintao Wang, 15068171732, jt_wang@sjtu.edu.cn
Gang Wang, MD, PhD
About this study
Official title: Shanghai Cognitive Impairment Study of the Elderly Population: SheMountain Cohort
This study is a prospective observational study, which involves a cohort of 2000 all-sex and all-ethnic people aged 60 years and above with permanent residence in Tianma area, SheMountain Town, Songjiang District (suburban area), Shanghai. Demographic information, neuropsychiatric scale, peripheral blood, APOE genotype, brain MRI, speech information, AV45-PET, FDG-PET, Tau-PET, GLP-1R PET, and cholinergic receptor probe (ASEM) PET were collected and analyzed. Follow-up visits were performed twice a year for 4 visits, and neuropsychiatric scales and biological samples were collected at each follow-up visit to construct a diagnostic model for patients with mild cognitive impairment, or Alzheimer's disease, as well as a predictive model for the progression of cognitive impairment.
Read the detailed description
This study is a prospective observational study, which involves a cohort of 2000 all-sex and all-ethnic people aged 60 years and above with permanent residence in Tianma area, SheMountain Town, Songjiang District (suburban area), Shanghai. Demographic information, neuropsychiatric scale, peripheral blood serum Aβ40, Aβ42, p-tau 181, 217, urine proteomic analysis, APOE genotype analysis, brain MRI, and speech information were collected and analyzed. After initial screening 20% of patients with clinically confirmed MCI and AD were randomly selected for AV45-PET, FDG-PET, Tau-PET, GLP-1R PET, and cholinergic receptor probe (ASEM) PET. Follow-up visits were performed twice a year for 4 visits, and neuropsychiatric scales and biological samples were collected at each follow-up visit to construct a diagnostic model for patients with mild cognitive impairment, or Alzheimer's disease, as well as a predictive model for the progression of cognitive impairment.
- Conditions
- Alzheimer Disease, Dementia, Neurodegenerative Diseases, Cognitive Impairment, Mild Cognitive Impairment
- Keywords
- Alzheimer disease, Mild cognitive impairment, cohort, Disease Progression
- Medical subject headings
- Alzheimer Disease, Dementia, Neurodegenerative Diseases, Cognitive Dysfunction, Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of incidence of cognitive impairment
Number of participants who covert to AD or mild cognitive impairment (MCI) will be recorded to calculate the incidence.
Measured: baseline, 2 year, 4 year, 6 year, 8 year
Secondary outcomes (10)
The change of Mini-Mental State Examination (MMSE)
MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. 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 Montreal cognitive assessment-Basic (MoCA)
MoCA is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. 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 Auditory verbal learning test (AVLT)
AVLT is a screening instrument used to assess the function of memory. The score in long-term memory (N5) ranges from 0 to 12, with lower scores indicating greater disease severity.
Measured: baseline, 2 year, 4 year, 6 year, 8 year
The change of Geriatric Depression Scale (GDS)
GDS is a neuropsychological scale used to assess the level of depression. The total score ranges from 0 to 30, with higher scores indicating greater disease severity.
Measured: baseline, 2 year, 4 year, 6 year, 8 year
The change of 36-Item Short Form Survey (SF-36)
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. And it consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: baseline, 2 year, 4 year, 6 year, 8 year
The change of MRI neuroimaging
Evaluation of brain MRI by high-resolution structural T1 imaging, diffusion tensor imaging, and blood oxygenation level dependent (BOLD) imaging.
Measured: baseline, 2 year, 4 year, 6 year, 8 year
Positron emission tomography (PET)-CT
Including AV45-PET, FDG-PET, Tau-PET, GLP-1R PET, Cholinergic receptor probe (ASEM) PET will be used to detect the amyloid, Tau burden and AD related GLP-1R as well as Cholinergic receptor change.
Measured: baseline
The change of blood concentration of Phosphorylated Tau, Concentration of Amyloid β (Aβ)
Blood serum p-tau 181, p-tau 217, Aβ40 and Aβ42at baseline will be tested. The higher blood p-tau is a strong predictor for AD.
Measured: baseline, 2 year, 4 year, 6 year, 8 year
The change of Activities of daily living (ADL)
ADL is a scale used in healthcare to refer to people's daily self-care activities. Eight factors are rated to produce an overall score on a point scale of 0 to 100. The lower the score the more independence in living.
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 use self-developed ASR speech analysis software (China software copyright number: 2016RS164680) for speech analysis.
Measured: baseline, 2 year, 4 year, 6 year, 8 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start26 Dec 2022 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Jan 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667935
- Sponsor's protocol ID
- SheMountain-01
- Acronym
- SheMountain
- Status last verified
- Dec 2022
- First submitted
- 13 Dec 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Cognitive Impairment Study of the Elderly Population: SheMountain Cohort
- ClinicalTrials.gov ID
- NCT05667935
- Acronym / sponsor ID
- SheMountain / SheMountain-01
- Conditions
- Alzheimer Disease, Dementia, Neurodegenerative Diseases, Cognitive Impairment, Mild Cognitive Impairment
- Keywords
- Alzheimer disease, Mild cognitive impairment, cohort, Disease Progression
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 26 Dec 2022 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 29 Dec 2022 (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 study is a prospective observational study, which involves a cohort of 2000 all-sex and all-ethnic people aged 60 years and above with permanent residence in Tianma area, SheMountain Town, Songjiang District (suburban area), Shanghai. Demographic information, neuropsychiatric scale, peripheral blood, APOE genotype, brain MRI, speech information, AV45-PET, FDG-PET, Tau-PET, GLP-1R PET, and cholinergic receptor probe (ASEM) PET were collected and analyzed. Follow-up visits were performed twice a year for 4 visits, and neuropsychiatric scales and biological samples were collected at each follow-up visit to construct a diagnostic model for patients with mild cognitive impairment, or Alzheimer's disease, as well as a predictive model for the progression of cognitive impairment.
Detailed description
This study is a prospective observational study, which involves a cohort of 2000 all-sex and all-ethnic people aged 60 years and above with permanent residence in Tianma area, SheMountain Town, Songjiang District (suburban area), Shanghai. Demographic information, neuropsychiatric scale, peripheral blood serum Aβ40, Aβ42, p-tau 181, 217, urine proteomic analysis, APOE genotype analysis, brain MRI, and speech information were collected and analyzed. After initial screening 20% of patients with clinically confirmed MCI and AD were randomly selected for AV45-PET, FDG-PET, Tau-PET, GLP-1R PET, and cholinergic receptor probe (ASEM) PET. Follow-up visits were performed twice a year for 4 visits, and neuropsychiatric scales and biological samples were collected at each follow-up visit to construct a diagnostic model for patients with mild cognitive impairment, or Alzheimer's disease, as well as a predictive model for the progression of cognitive impairment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population in this study includes permanent residence in SheMountain Town, Songjiang District (suburbs), Shanghai with all genders and all ethnic groups aged 60 and above.
Key inclusion criteria (3 listed)
- All genders and all ethnic groups aged 60 and above with permanent residence in Tianma area, SheMountain Town, Songjiang District (suburbs), Shanghai.
- Agree to collect neuropsychiatric scales, biological samples, imaging and other examination information.
- Agree to participate in this study and sign the informed consent form. And promise to abide by the research procedures, and cooperate with the implementation of the whole process of research
Key exclusion criteria (2 listed)
- Suffering from severe mental illness, tumor cachexia, severe liver and kidney dysfunction and other serious physical diseases and unable to cooperate
- Uncorrectable visual or auditory impairment that hampers the completion of related examination.
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 incidence of cognitive impairment
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
Number of participants who covert to AD or mild cognitive impairment (MCI) will be recorded to calculate the incidence.
10 secondary outcomes
The change of Mini-Mental State Examination (MMSE)
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
The change of Montreal cognitive assessment-Basic (MoCA)
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
The change of Auditory verbal learning test (AVLT)
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
The change of Geriatric Depression Scale (GDS)
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
The change of 36-Item Short Form Survey (SF-36)
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
The change of MRI neuroimaging
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
Positron emission tomography (PET)-CT
Time frame: baseline
The change of blood concentration of Phosphorylated Tau, Concentration of Amyloid β (Aβ)
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
The change of Activities of daily living (ADL)
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
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 29 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
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 Dementia, 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 3 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: opening soon, as of the sponsor's last update on 29 Dec 2022. 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?
The change of incidence of cognitive impairment (time frame: baseline, 2 year, 4 year, 6 year, 8 year). 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 29 Dec 2022.