Alzheimer DiseaseNCT06827678
Establishment of the Chinese Preclinical Alzheimer's Disease Study With Multiple Neuroimaging
An observational study of Alzheimer Disease and Positron Emission Tomography, run by Huashan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Positron Emission Tomography
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 30 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants are recruited from neurology outpatient clinics and community settings.
Who may be able to join
- Cognitive unimpaired(CU) controls:
- 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;
Show all 11Show fewer
- 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).
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai
Yihui Guan, MD, +8613764308300 ext. +86, guanyihui@hotmail.com
Fang Xie, PhD
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease, Positron Emission Tomography
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Alzheimer's Disease, PET imaging, Biomarker, Body Imaging
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Chinese Preclinical Alzheimer's Disease Study | This cohort will included AD, MCI and Cognitively un-impairments. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 90 minutes post-injection
Secondary outcomes (3)
Multi-sequence MR Imaging Data Collection
This multi-sequence MRI approach allows for the early detection of neurodegenerative changes, tracking of synaptic and vascular alterations, and identification of atrophy patterns associated with cognitive decline. Each subject underwent MRI scanning using a Siemens Prisma 3.0T research MRI scanner. The acquisition sequences included T1WI, T2WI, DTI, ASL, SWI, and rs-fMRI, which provide comprehensive structural, functional, and perfusion-related information on brain integrity. These sequences were also collected during follow-up assessments.
Measured: A 5-year follow-up with assessments conducted annually.
Peripheral Blood Biomarker Collection
Blood-based biomarkers offer a minimally invasive method for detecting Alzheimer's disease-related pathology and monitoring disease progression , including tau pathology, neuroinflammation, and glial activation. Peripheral blood biomarker data, including p-tau181, p-tau231, p-tau217, GFAP, sTREM2, etc., were collected to assess neurodegeneration and neuroinflammation. Plasma samples were stored at -80 °C and analyzed using the Quanterix Simoa HD-1 platform. Measurements were conducted by technicians blinded to clinical imaging data. The concentrations of these plasma biomarkers are presented in pg/mL.
Measured: A 5-year follow-up with assessments conducted annually.
Neuropsychological Scale Assessment
Neuropsychological assessments provide crucial insights into cognitive decline, aiding in the early diagnosis of Alzheimer's disease and other dementias. Cognitive function was assessed using standardized neuropsychological scales, including MMSE (minimum value 0, maximum value 30, higher scores indicate better cognitive function) and MoCA-B (minimum value 0, maximum value 30, higher scores indicate better cognitive function), among others.
Measured: A 5-year follow-up with assessments conducted annually.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Aug 2022
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YiHui Guan, Huashan Hospital
- Investigators
- Fang Xie, PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827678
- Sponsor's protocol ID
- KY2024-723
- Status last verified
- Jun 2025
- First submitted
- 5 Dec 2024
- Last updated
- 5 Jun 2025
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of the Chinese Preclinical Alzheimer's Disease Study With Multiple Neuroimaging
- ClinicalTrials.gov ID
- NCT06827678
- Acronym / sponsor ID
- KY2024-723
- Conditions
- Alzheimer Disease, Positron Emission Tomography
- Keywords
- Alzheimer's Disease, PET imaging, Biomarker, Body Imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese Preclinical Alzheimer's Disease Study | – | Other: No Intervention: Observational CohortThis cohort will included AD, MCI and Cognitively un-impairments. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are recruited from neurology outpatient clinics and community settings.
Key inclusion criteria (11 listed)
- Cognitive unimpaired(CU) controls:
- 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;
Key exclusion criteria (11 listed)
- All subjects:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo intervention | Other | Chinese Preclinical Alzheimer's Disease Study |
Primary outcome
Evaluation of Synaptic Density in Alzheimer's Disease Using Synaptic Vesicle Glycoprotein 2A (SV2A) PET Tracer [¹⁸F]SDM-8
Time frame: 90 minutes post-injection
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.
Evaluation of Neuronal Function in Alzheimer's Disease Using Metabotropic Glutamate Receptor 5 (mGluR5) PET Tracer [¹⁸F]PS232
Time frame: 90 minutes post-injection
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.
3 secondary outcomes
Multi-sequence MR Imaging Data Collection
Time frame: A 5-year follow-up with assessments conducted annually.
Peripheral Blood Biomarker Collection
Time frame: A 5-year follow-up with assessments conducted annually.
Neuropsychological Scale Assessment
Time frame: A 5-year follow-up with assessments conducted annually.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fang Xie, PhD principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Positron Emission Tomography, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yihui Guan, MD (+8613764308300 ext. +86, guanyihui@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Synaptic Density in Alzheimer's Disease Using Synaptic Vesicle Glycoprotein 2A (SV2A) PET Tracer [¹⁸F]SDM-8 (time frame: 90 minutes post-injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.