An observational study in Alzheimer Disease, Dementia and Neurodegenerative Diseases, sponsored by Ruijin Hospital. Not yet recruiting at 1 site in China. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-29.
Sponsored by Ruijin Hospital · Observational
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.
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
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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.
Exclusion Criteria:
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.
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, 2 year, 4 year, 6 year, 8 year
Plan to share: Undecided
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Ruijin Hospital