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Recruiting NCT06534658

Study on Multimodal Imaging and Molecular Imaging Techniques in Degenerative Dementia

— Observational Alzheimer Disease Image

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Alzheimer Disease, Image. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • The change of incidence of cognitive impairment [Time frame: baseline, 1 year, 2 year, 3 year, 4 year]
Secondary outcome measures (12)
  • The change of Mini-Mental State Examination (MMSE) [Time frame: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of Montreal cognitive assessment-Basic (MoCA) [Time frame: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of Auditory verbal learning test (AVLT) [Time frame: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of structural MRI [Time frame: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of functional MRI [Time frame: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of magnetic susceptibility [Time frame: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of perfusion MR imaging [Time frame: baseline, 1 year, 2 year, 3 year, 4 year]
  • Positron emission tomography (PET)-MRI [Time frame: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of blood biomarker [Time frame: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of speech information [Time frame: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of Activities of daily living (ADL) [Time frame: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of Geriatric Depression Scale (GDS) [Time frame: baseline, 1 year, 2 year, 3 year, 4 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 8 centers
  • Chinese People's Liberation Army General Hospital — Beijing
  • First Affiliated Hospital of Zhejiang University School of Medicine — Hanzhong
  • Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine — Cangzhou
  • The Second Hospital of Hebei Medical University — Shijiazhuang
  • Qilu Hospital of Shandong University, Qingdao Branch — Qingdao
  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai
  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai
  • The First Affiliated Hospital of China Medical University — Shenyang

Identifiers

NCT: NCT06534658 · BP-MIMI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗