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NCT Number: NCT06325527

Cognitive Impairment Cohort Study of the Elderly Population in YuGarden

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

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Location contact

Gang Wang

PRINCIPAL_INVESTIGATOR

Jinwen Xiao

CONTACT

[email protected]

13917310784

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

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 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.

  2. The change of Barthel Index for Activities of Daily Living (ADL)

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

    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.

  3. The change of blood biomarkers

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

    p-tau 181, p-tau 217, pE-Aβ3-42, Aβ40, Aβ42, GFAP and NFL will be detected.

  4. The change of urine biomarkers

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

    The metabolomic markers in urine will be detected by mass spectrum analysis.

  5. The change of feces biomarkers

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

    The metabolomic markers in feces will be detected by mass spectrum analysis.

  6. The change of gingival crevicular fluid biomarkers

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

    The metabolomic profiles of gingival crevicular fluid will be detected by mass spectrum analysis.

  7. The change of electroencephalogram (EEG)

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

    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.

  8. 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 the self-developed ASR speech analysis software (China software copyright number: 2016RS164680) will be used for speech analysis.

  9. The change of structural MRI

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

    Structural MRI data will be acquired and analyzed through high-resolution T1-weighted MRI and diffusion tensor imaging (DTI).

  10. The change of functional MRI

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

    Functional MRI data will be acquired and analyzed through blood oxygenation level dependent (BOLD) imaging.

  11. The change of magnetic susceptibility

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

    Magnetic susceptibility data will be acquired and analyzed through quantitative susceptibility mapping (QSM).

  12. The change of perfusion MR imaging

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

    Perfusion imaging data will be acquired and analyzed through arterial spin labeling (ASL).

  13. Positron emission tomography (PET)

    Time frame: baseline

    PET including FDG-PET, Aβ-PET, Tau-PET will be used to detect brain β-amyloid and tau burden.

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: YuGarden Cohort

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Mar 22, 2024
Registry last updated
Mar 22, 2024

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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