Study on Multimodal Imaging and Molecular Imaging Techniques in Degenerative Dementia
NCT Number: NCT06534658
Acronym: MIMI
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Alzheimer Disease|Image
Sponsor: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-07-30
Completion Date: 2029-08-30
Locations: Chinese People's Liberation Army General Hospital, Beijing, Beijing, China|First Affiliated Hospital of Zhejiang University School of Medicine, Hanzhong, Hangzhou, China|Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, Cangzhou, Hebei, China|The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China|Qilu Hospital of Shandong University, Qingdao Branch, Qingdao, Shandong, China|Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, 200025, China|Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, 200025, China|The First Affiliated Hospital of China Medical University, Shenyang, Shenyang, China

Summary:
This project is a multicenter observational study that establishes a longitudinal cohort of patients with Alzheimer's disease and other dementias based on neuroimaging, molecular imaging, biological and digital markers to explore new solutions such as dementia disease mechanism, diagnosis, condition evaluation, and prognosis assessment.

Primary Outcome Measures: 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, 1 year, 2 year, 3 year, 4 year
Secondary Outcome Measures: 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, 1 year, 2 year, 3 year, 4 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., baseline, 1 year, 2 year, 3 year, 4 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., baseline, 1 year, 2 year, 3 year, 4 year|The change of structural MRI, Structural MRI data will be acquired and analyzed through high-resolution T1-weighted MRI and diffusion tensor imaging (DTI)., baseline, 1 year, 2 year, 3 year, 4 year|The change of functional MRI, Functional MRI data will be acquired and analyzed through blood oxygenation level dependent (BOLD) imaging., baseline, 1 year, 2 year, 3 year, 4 year|The change of magnetic susceptibility, Magnetic susceptibility data will be acquired and analyzed through quantitative susceptibility mapping (QSM), baseline, 1 year, 2 year, 3 year, 4 year|The change of perfusion MR imaging, Perfusion imaging data will be acquired and analyzed through arterial spin labeling (ASL)., baseline, 1 year, 2 year, 3 year, 4 year|Positron emission tomography (PET)-MRI, 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, 1 year, 2 year, 3 year, 4 year|The change of blood biomarker, Blood serum p-tau 181, p-tau 217, Aβ40, pEAβ3-42 and Aβ42 , GFAP, NFL at baseline will be tested. The higher blood p-tau is a strong predictor for AD., baseline, 1 year, 2 year, 3 year, 4 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., baseline, 1 year, 2 year, 3 year, 4 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., baseline, 1 year, 2 year, 3 year, 4 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., baseline, 1 year, 2 year, 3 year, 4 year|The change of electroencephalogram (EEG), 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., baseline, 1 year, 2 year, 3 year, 4 year