Clinical trial NCT06827678: Establishment of the Chinese Preclinical Alzheimer's Disease Study With Multiple Neuroimaging
Official title: Establishment of the Chinese Preclinical Alzheimer's Disease Study With Multiple Neuroimaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Positron Emission Tomography
Keywords: Alzheimer&#39;s Disease
PET imaging
Biomarker
Body Imaging
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 3000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are recruited from neurology outpatient clinics and community settings.

Brief summary: The goal of this observational study is to investigate neuroimage and biomarkers in the Alzheimer's continuum in Chinese population. We aimed to:

* To reveal the progress of AD by multiple neuroimage and biomarkers;
* To reveal the longitudinal change of biomarkers and cognition of AD in Chinese population;
* To investigate the interaction of markers between body and brain;
* To set up new markers by neuroimage.

Detailed description: The observational study is recruiting participants from clinics and communities with cognitive impairments and un-impairments. As the part of our previous study: Chinese Preclinical Alzheimer's Disease Study (C-PAS) cohort. We will include lager size of body and brain PET imaging. The study will also integrate multi-dimensional scales, peripheral biomarkers, metabolites, electroencephalograms, genetics, and other indicators for multi-omics analysis to deeply explore the mechanisms underlying the onset and progression of Alzheimer's disease. By identifying risk factors closely associated with Alzheimer's disease, we aim to develop a comprehensive disease risk model, providing reliable evidence for early detection and prevention, and uncovering new targets for therapeutic interventions.

Eligibility criteria: Inclusion Criteria:

1. Cognitive unimpaired(CU) controls:

(1) Aged between 45 and 90 years; no gender restrictions； (2) Cognitive function is assessed as normal by the researcher based on cognitive tests, with a Clinical Dementia Rating (CDR) score of 0; (3) Confirmed by the researcher to have no neurological diseases, major chronic illnesses, malignant tumors, or acute infectious diseases; (4) No family history of Alzheimer's disease (AD) or other neurological diseases related to cognitive impairment and movement disorders; (5) Able to understand and provide written informed consent before any assessment; (6) Female subjects must provide medical documentation proving they have undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) or have been menopausal for over one year. If they are still of childbearing potential, they must use effective contraceptive measures during the study; (7) Male subjects must use effective contraceptive measures during the study period and are prohibited from donating sperm during this time; (8) Willing and able to comply with all study procedures. 2. Cognitive impaired(CI) patients:

1. Aged between 45 and 90 years; no gender restrictions;
2. CDR score ≥ 0.5;
3. MMSE score ≤ 24;
4. Brain MRI findings support the diagnosis of AD, with no evidence of other neurological diseases;
5. Any medications taken to alleviate AD symptoms must be maintained at a stable dose for at least 30 days before study participation;
6. Written informed consent must be provided by the subject or their legal guardian/caregiver;
7. If necessary, subjects may be accompanied by a caregiver;
8. Before any assessment, the subject or their legal representative must understand and sign a written informed consent form;
9. Female subjects must provide medical documentation confirming surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation).

Exclusion Criteria:

* All subjects:

  1. Presence of severe neurological diseases or serious disorders affecting the gastrointestinal, cardiovascular, hepatic, renal, hematologic, oncologic, endocrine, respiratory, or immune systems;
  2. Presence of MRI-incompatible metal implants, including cardiac pacemakers, intravascular metal devices, insulin pumps, cochlear implants, nerve stimulators, or cerebral aneurysm clips;
  3. Inability to tolerate MRI noise or a history of claustrophobia;
  4. Exposure to ionizing radiation exceeding 50 mSv within the past year due to participation in other clinical or scientific research;
  5. History of drug or alcohol abuse;
  6. Pregnancy or lactation;
  7. Poor venous access, making repeated venipuncture infeasible;
  8. Use of experimental drugs or devices with unknown efficacy or safety within the past month;
  9. Allergy to any components of the tracer injection;
  10. Any condition that, in the investigator's judgment, may pose a risk or compromise the integrity of the study.

Primary outcomes:
measure: Evaluation of Synaptic Density in Alzheimer's Disease Using Synaptic Vesicle Glycoprotein 2A (SV2A) PET Tracer [¹⁸F]SDM-8
timeFrame: 90 minutes post-injection
measure: Evaluation of Neuronal Function in Alzheimer's Disease Using Metabotropic Glutamate Receptor 5 (mGluR5) PET Tracer [¹⁸F]PS232
timeFrame: 90 minutes post-injection
Secondary outcomes:
measure: Multi-sequence MR Imaging Data Collection
timeFrame: A 5-year follow-up with assessments conducted annually.
measure: Peripheral Blood Biomarker Collection
timeFrame: A 5-year follow-up with assessments conducted annually.
measure: Neuropsychological Scale Assessment
timeFrame: A 5-year follow-up with assessments conducted annually.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
Study officials:
affiliation: Huashan Hospital
name: Fang Xie, PhD
role: PRINCIPAL_INVESTIGATOR
References: