NCT Number: NCT06534658
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.
Interested in participating?
Request Info50 year–85 year
All sexes
Observational
Chinese People's Liberation Army General Hospital, Beijing, Beijing Municipality, China
This project will build a longitudinal database based on multimodal MRI imaging information of dementia subjects, various body fluid or digital markers, and a cohort. The convolutional neural network algorithm will be used to explore the imaging characteristics of healthy controls, AD, FTD, and DLB, develop an early prediction model for degenerative dementia, and achieve early differential diagnosis of different dementia subtypes. This study further performed GE180, ASEM, and exendin-4 radionuclide imaging on some subjects who completed conventional PET (AV45, Tauvir, and FDG) imaging to explore the diagnostic efficacy of these three probes as new diagnostic probes for early AD. In addition, through longitudinal follow-up of Aβ-positive MCI patients, multimodal MRI and PET image fusion technology were used to explore the changes in fused images during their conversion to AD in order to obtain early and accurate diagnostic markers.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: baseline, 1 year, 2 year, 3 year, 4 year
Number of participants who covert to AD or mild cognitive impairment (MCI) will be recorded to calculate the incidence.
Time frame: baseline, 1 year, 2 year, 3 year, 4 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.
Time frame: baseline, 1 year, 2 year, 3 year, 4 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.
Time frame: baseline, 1 year, 2 year, 3 year, 4 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.
Time frame: baseline, 1 year, 2 year, 3 year, 4 year
Structural MRI data will be acquired and analyzed through high-resolution T1-weighted MRI and diffusion tensor imaging (DTI).
Time frame: baseline, 1 year, 2 year, 3 year, 4 year
Functional MRI data will be acquired and analyzed through blood oxygenation level dependent (BOLD) imaging.
Time frame: baseline, 1 year, 2 year, 3 year, 4 year
Magnetic susceptibility data will be acquired and analyzed through quantitative susceptibility mapping (QSM)
Time frame: baseline, 1 year, 2 year, 3 year, 4 year
Perfusion imaging data will be acquired and analyzed through arterial spin labeling (ASL).
Time frame: baseline, 1 year, 2 year, 3 year, 4 year
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, 1 year, 2 year, 3 year, 4 year
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.
Time frame: baseline, 1 year, 2 year, 3 year, 4 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.
Time frame: baseline, 1 year, 2 year, 3 year, 4 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.
Time frame: baseline, 1 year, 2 year, 3 year, 4 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.
Time frame: baseline, 1 year, 2 year, 3 year, 4 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.
Contact information is provided by the study sponsor or research team.
Ruijin Hospital
Other
Acronym: MIMI
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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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