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NCT Number: NCT05667935

Cognitive Impairment Cohort Study of the Elderly Population in SheMountain

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Dementia Disease Attributes Disease Progression Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location contact

Gang Wang, MD, PhD

PRINCIPAL_INVESTIGATOR

Jintao Wang

CONTACT

[email protected]

15068171732

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. The change of Mini-Mental State Examination (MMSE)

    Time frame: baseline, 2 year, 4 year, 6 year, 8 year

    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.

  2. The change of Montreal cognitive assessment-Basic (MoCA)

    Time frame: baseline, 2 year, 4 year, 6 year, 8 year

    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.

  3. The change of Auditory verbal learning test (AVLT)

    Time frame: baseline, 2 year, 4 year, 6 year, 8 year

    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.

  4. The change of Geriatric Depression Scale (GDS)

    Time frame: baseline, 2 year, 4 year, 6 year, 8 year

    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.

  5. The change of 36-Item Short Form Survey (SF-36)

    Time frame: baseline, 2 year, 4 year, 6 year, 8 year

    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.

  6. The change of MRI neuroimaging

    Time frame: baseline, 2 year, 4 year, 6 year, 8 year

    Evaluation of brain MRI by high-resolution structural T1 imaging, diffusion tensor imaging, and blood oxygenation level dependent (BOLD) imaging.

  7. Positron emission tomography (PET)-CT

    Time frame: baseline

    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.

  8. The change of blood concentration of Phosphorylated Tau, Concentration of Amyloid β (Aβ)

    Time frame: baseline, 2 year, 4 year, 6 year, 8 year

    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.

  9. The change of Activities of daily living (ADL)

    Time frame: baseline, 2 year, 4 year, 6 year, 8 year

    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.

  10. The change of speech information

    Time frame: baseline, 2 year, 4 year, 6 year, 8 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gang Wang, MD, PhD

CONTACT

[email protected]

086-021-64370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Shanghai Cognitive Impairment Study of the Elderly Population: SheMountain Cohort

Acronym: SheMountain

Important dates

Study start
2022
Primary completion
2030
Study completion
2031
First posted
Dec 29, 2022
Registry last updated
Dec 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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