Cognitive Impairment Cohort Study of the Elderly Population in SheMountain

Alzheimer Disease Clinical Trial

— SheMountain  

Official title:

Shanghai Cognitive Impairment Study of the Elderly Population: SheMountain Cohort

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05667935
• Other study ID #: SheMountain-01
• Status: Not yet recruiting
• Start date: December 26, 2022
• Est. completion date: January 31, 2031

Study information

• Verified date: December 2022
• Source: Ruijin Hospital
• Contact: Gang Wang, MD, PhD
• Phone: 086-021-64370045
• Email: wg11424[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: January 31, 2031
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. All genders and all ethnic groups aged 60 and above with permanent residence in Tianma area, SheMountain Town, Songjiang District (suburbs), Shanghai.

2. Agree to collect neuropsychiatric scales, biological samples, imaging and other examination information.

3. 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:

1. Suffering from severe mental illness, tumor cachexia, severe liver and kidney dysfunction and other serious physical diseases and unable to cooperate

2. Uncorrectable visual or auditory impairment that hampers the completion of related examination.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Mild Cognitive Impairment
• Neurodegenerative Diseases

Locations

Country	Name	City	State
China	Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 2 year, 4 year, 6 year, 8 year
Secondary	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.	baseline, 2 year, 4 year, 6 year, 8 year
Secondary	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.	baseline, 2 year, 4 year, 6 year, 8 year
Secondary	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.	baseline, 2 year, 4 year, 6 year, 8 year
Secondary	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.	baseline, 2 year, 4 year, 6 year, 8 year
Secondary	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.	baseline, 2 year, 4 year, 6 year, 8 year
Secondary	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.	baseline, 2 year, 4 year, 6 year, 8 year
Secondary	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.	baseline
Secondary	The change of blood concentration of Phosphorylated Tau, Concentration of Amyloid ß (Aß)	Blood serum p-tau 181, p-tau 217, Aß40 and Aß42at baseline will be tested. The higher blood p-tau is a strong predictor for AD.	baseline, 2 year, 4 year, 6 year, 8 year
Secondary	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.	baseline, 2 year, 4 year, 6 year, 8 year
Secondary	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.	baseline, 2 year, 4 year, 6 year, 8 year