Study on Multimodal Imaging and Molecular Imaging Techniques in Degenerative Dementia

NCT ID: NCT06534658

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-30
• Study Completion Date: 2029-08-30

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.

Conditions

Alzheimer Disease; Image

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gang Wang, PhD. MD.

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

First Affiliated Hospital of Zhejiang University School of Medicine

Hanzhong, Hangzhou, China

Site Status: RECRUITING

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Cangzhou, Hebei, China

Site Status: RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status: RECRUITING

Qilu Hospital of Shandong University, Qingdao Branch

Qingdao, Shandong, China

Site Status: RECRUITING

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Shenyang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jintao Wang

Role: CONTACT

jt_wang@sjtu.edu.cn

18221457023 ext. 86

Facility Contacts

Yan Chang

Role: primary

Guoping Peng

Role: primary

Ronghua Dou

Role: primary

Fang Yuan

Role: primary

Jintao Wang

Role: primary

Yafu Yin

Role: primary

Xuena Li

Role: primary

Other Identifiers

BP-MIMI

Identifier Type: -

Identifier Source: org_study_id