Establishment of the Chinese Preclinical Alzheimer's Disease Study With Multiple Neuroimaging

NCT06827678 | Recruiting

• 1 other identifier: KY2024-723
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Positron Emission Tomography

Keywords

Alzheimer's Disease; PET imaging; Biomarker; Body Imaging

Outcome Measures

Primary Outcomes (2)

• Evaluation of Synaptic Density in Alzheimer's Disease Using Synaptic Vesicle Glycoprotein 2A (SV2A) PET Tracer [¹⁸F]SDM-8

  Subjects received an intravenous injection of the radiopharmaceutical at a dose of 1.8 MBq/kg (0.05 mCi/kg). After a 90-minute rest in a quiet, light-controlled room, PET imaging was performed using a PET/CT or PET/MRI scanner with a dedicated head protocol. Scanning was conducted in 3D mode (FOV: 180 mm), and images were reconstructed using the 3D RAMLA algorithm at a resolution of 2×2×2 mm. PET images were co-registered with structural CT or MRI scans. For quantitative analysis, target regions, including cortical areas and the cerebellum, were delineated on normalized structural images and projected onto PET images to measure radiotracer uptake. The standardized uptake value ratio (SUVr) was calculated as the ratio of cortical to cerebellar uptake.

  90 minutes post-injection

• Evaluation of Neuronal Function in Alzheimer's Disease Using Metabotropic Glutamate Receptor 5 (mGluR5) PET Tracer [¹⁸F]PS232

  Subjects received an intravenous injection of the radiopharmaceutical at a dose of 1.8 MBq/kg (0.05 mCi/kg). After a 90-minute rest in a quiet, light-controlled room, PET imaging was performed using a PET/CT or PET/MRI scanner with a dedicated head protocol. Scanning was conducted in 3D mode (FOV: 180 mm), and images were reconstructed using the 3D RAMLA algorithm at a resolution of 2×2×2 mm. PET images were co-registered with structural CT or MRI scans. For quantitative analysis, target regions, including cortical areas and the cerebellum, were delineated on normalized structural images and projected onto PET images to measure radiotracer uptake. The standardized uptake value ratio (SUVr) was calculated as the ratio of cortical to cerebellar uptake.

  90 minutes post-injection

Secondary Outcomes (3)

• Multi-sequence MR Imaging Data Collection

  A 5-year follow-up with assessments conducted annually.

• Peripheral Blood Biomarker Collection

  A 5-year follow-up with assessments conducted annually.

• Neuropsychological Scale Assessment

  A 5-year follow-up with assessments conducted annually.

Study Arms (1)

Chinese Preclinical Alzheimer's Disease Study

This cohort will included AD, MCI and Cognitively un-impairments.

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No intervention

Chinese Preclinical Alzheimer's Disease Study

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are recruited from neurology outpatient clinics and community settings.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA from Blood will be collected

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Fang Xie, PhD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yihui Guan, MD

CONTACT

+8613764308300; guanyihui@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: February 14, 2025
• Study Start: August 1, 2022
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

CN (1)