Clinical trial NCT06534658: Study on Multimodal Imaging and Molecular Imaging Techniques in Degenerative Dementia
Official title: Study on Multimodal Imaging and Molecular Imaging Techniques in Degenerative Dementia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Image
Keywords: Alzheimer Disease
molecular imaging
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population in this study includes the cognitive impairment patients in Ruijin Hospital, Renji Hospital, The First Hospital of Zhejiang University School of Medicine, The First Hospital of China Medical University.

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥50 and ≤85 years old, male or female;
* Meet the diagnostic criteria for dementia or MCI;
* Neuropsychological score: MMSE 15-28 points, CDR ≤ 1 point; ④ Patients and their families are informed and sign the informed consent form

Exclusion Criteria:

* The presence of other neurological diseases that may cause brain dysfunction (such as depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal intracranial pressure hydrocephalus, etc.);
* The presence of other systemic diseases that may cause cognitive impairment (such as liver dysfunction, renal dysfunction, thyroid dysfunction, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.);
* Suffering from a disease that makes it impossible to cooperate with cognitive examinations;
* The presence of contraindications to MRI;
* The presence of mental and neurological retardation;
* Refusing to draw blood;
* Refusing to sign the informed consent form.

Primary outcomes:
measure: The change of incidence of cognitive impairment
timeFrame: baseline, 1 year, 2 year, 3 year, 4 year
Secondary outcomes:
measure: The change of Mini-Mental State Examination (MMSE)
timeFrame: baseline, 1 year, 2 year, 3 year, 4 year
measure: The change of Montreal cognitive assessment-Basic (MoCA)
timeFrame: baseline, 1 year, 2 year, 3 year, 4 year
measure: The change of Auditory verbal learning test (AVLT)
timeFrame: baseline, 1 year, 2 year, 3 year, 4 year
measure: The change of structural MRI
timeFrame: baseline, 1 year, 2 year, 3 year, 4 year
measure: The change of functional MRI
timeFrame: baseline, 1 year, 2 year, 3 year, 4 year
measure: The change of magnetic susceptibility
timeFrame: baseline, 1 year, 2 year, 3 year, 4 year
measure: The change of perfusion MR imaging
timeFrame: baseline, 1 year, 2 year, 3 year, 4 year
measure: Positron emission tomography (PET)-MRI
timeFrame: baseline, 1 year, 2 year, 3 year, 4 year
measure: The change of blood biomarker
timeFrame: baseline, 1 year, 2 year, 3 year, 4 year
measure: The change of speech information
timeFrame: baseline, 1 year, 2 year, 3 year, 4 year
measure: The change of Activities of daily living (ADL)
timeFrame: baseline, 1 year, 2 year, 3 year, 4 year
measure: The change of Geriatric Depression Scale (GDS)
timeFrame: baseline, 1 year, 2 year, 3 year, 4 year
measure: The change of electroencephalogram (EEG)
timeFrame: baseline, 1 year, 2 year, 3 year, 4 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese People's Liberation Army General Hospital
state: Beijing
city: Hanzhong
country: China
facility: First Affiliated Hospital of Zhejiang University School of Medicine
state: Hangzhou
city: Cangzhou
country: China
facility: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Qingdao
country: China
facility: Qilu Hospital of Shandong University, Qingdao Branch
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Shenyang
Study officials:
affiliation: RenJi Hospital
name: Gang Wang, PhD. MD.
role: PRINCIPAL_INVESTIGATOR
References: