Alzheimer DiseaseNCT04696315
Early Diagnosis of SCD Based on Radiogenomics
An observational study of Alzheimer Disease and Subjective Cognitive Decline, run by Ying Han at 1 site in China.
Trial summary
The incidence of AD dementia is increasing due to the aging population, putting a heavy burden on our society and economics. Exploring the mechanisms underlying SCD due to preclinical AD has scientific and clinical significance. Read more about this study
- Who is it for?
- Ages 60 to 79 years
- Conditions the study is for
- Alzheimer Disease, Subjective Cognitive Decline, Neuroimaging
- What is being tested?
- Multiple features extraction
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 to 79 years
- All sexes
- Adult, Older adult
Study population: SCD may serve as a first symptomatic indicator during the preclinical stage of AD. SCD with amyloidopathy had a risk of progressing to AD dementia. In this study, all participants from two centers in Germany and China will be classified into two groups (SCD with amyloid+ and SCD with amyloid-) based on the amyloid PET. In addition, the participants will conduct multiple parameter MRI scanning, clinical data collection, blood biomarkers and gene examination. The investigators aim to reveal the common risk factors associated with amyloid deposition based on clinical, neuroimaging, and genetic information from two countries.
Who may be able to join
- 60-79 years old, right-handed and Mandarin-speaking subjects;
- self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event;
- normal age-, gender- and education-adjusted performance on standardised cognitive tests;
- concerns (worries) associated with memory complaint;
- failure to meet the criteria for MCI or dementia
Who cannot join
- a history of stroke;
- major depression (Hamilton Depression Rating Scale score > 24 points);
- other central nervous system diseases that may cause cognitive impairment, such as Parkinson's disease, tumors, encephalitis and epilepsy;
- cognitive impairment caused by traumatic brain injury;
- systemic diseases, such as thyroid dysfunction, syphilis and HIV;
- a history of psychosis or congenital mental growth retardation
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurolgy, Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
Official title: Comparison of Subjective Cognitive Decline Between the German and Chinese and Early Diagnosis of Alzheimer's Disease Based on Radiogenomics
The incidence of AD dementia is increasing due to the aging population, putting a heavy burden on our society and economics. Exploring the mechanisms underlying SCD due to preclinical AD has scientific and clinical significance. However, it is challenging to construct and validate the preclinical diagnosis model of AD with fused multimodel information across culture/race. From the cooperation during the past five years, we have established cohorts by synchronized assessment, achieved consensus on SCD features extraction and made a breakthrough in the application of multiple parameter MRI with German collaborators. Therefore, in this project, SCD with and without amyloid pathology will be compared by clinical and cognitive data, genetics, blood and MRI biomarkers between the German and Chinese. Key features will be extracted and specific characteristics of SCD due to preclinical AD as well as risk factors for conversion between two countries will be clarified. Then the diagnosis model of preclinical AD in SCD will be established across culture/race based on radiogenomics, which will improve the current diagnostic system of AD. Through this project, the value of SCD in the etiologic, anatomical and quantitative diagnosis of preclinical AD will be identified to improve sensitivity and specificity of preclinical AD diagnosis in clinical practice.
Read the detailed description
The overall prevalence of dementia worldwide is increasing, imposing a heavy burden on the public and health care systems. Subjective cognitive decline (SCD), characterized by a self-report of decline in cognitive function without objective impairment in neuropsychological assessments, is considered a high risk factor for AD. SCD with amyloidopathy is considered as a first symptomatic indicator of the preclinical AD (SCD due to preclinical AD). However, how to construct and validate the preclinical diagnosis model of AD with fused multimodel information across culture/race remain unclear.
In the present study, all SCD participants from Germany and China will be conducted amyloid PET scanning, and they will be classified into two groups (SCD with amyloid+ and SCD with amyloid-) based on whether there is the evidence of amyloid deposition. The investigators will compare the clinical information, genetics, blood and multiple parameter MRI data between the German and Chinese to evaluate the common and specific features from different culture/race. Then, key features associated with amyloid deposition will be extracted for the establisment of diagnosis model of SCD due to preclinical AD, which will improve the current diagnostic system of AD. After four-year follow-up, SCD will be classified into SCD converter group and SCD non-converter group. Risk factors for conversion to cognitive impairment and dementia will be further extracted as predicted biomarkers.
Through this project, the value of SCD in the etiologic, anatomical and quantitative diagnosis of preclinical AD will be identified to improve sensitivity and specificity of preclinical AD diagnosis in clinical practice.
- Conditions
- Alzheimer Disease, Subjective Cognitive Decline, Neuroimaging, Gene
- Being tested
- Multiple features extraction
- Keywords
- Subjective Cognitive Decline, Radiogenomics
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple features extractionDiagnostic test
In the present study, the "gold standard" of preclinical AD is amyloid PET. SCD with positive amyloid is the target population for early AD intervention. The investigators aim to extract the diagnostic features from multiple parameter MRI, genetic, blood and clinical data using Max-Relevance and Min-Redundancy (mRMR) algorithm. Then, based on support vector machine (SVM), random forest (RF) and multi-kernel learning (MKL) classification methods, the investigators will construct predicted diagnostic model of preclinical AD.
| Study group | Role | What they receive |
|---|---|---|
| SCD subjects with positive amyloid | In this study, the participants are from two research centers in China and Germany. All participants will conduct amyloid PET scanning, after which they are classified into two grous (SCD with amyloid+ and SCD with amyloid-). SCD subjects with positive amyloid show the evidence of amyloid deposition in brain. They have higher risk of conversion to mild cognitive impairment and dementia compared with SCD with negative amyloid. They are also considered as preclinical AD. Receives: Diagnostic Test: Multiple features extraction | |
| SCD subjects with negative amyloid | In this study, the participants are from two research centers in China and Germany. All participants will conduct amyloid PET scanning, after which they are classified into two grous (SCD with amyloid+ and SCD with amyloid-). SCD subjects with negative amyloid do not show the evidence of amyloid deposition in brain. They have lower risk of conversion to mild cognitive impairment and dementia compared with SCD with positive amyloid. Receives: Diagnostic Test: Multiple features extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers associated with amyloid deposition
SCD with the evidence of brain amyloid deposition is considered as preclinical AD. The investigators aim to extract multiple features involving neuroimaging, gene sequencing, blood, and clinical data to identify individuals with amyloid+ from SCD persons. These features associated with amyloid deposition are valuable biomarkers for early diagnosis of AD.
Measured: Four years
Secondary outcomes (1)
Predicted biomarkers associated with conversion to cognitive impairment
Individuals with SCD will be followed for four years. The investigators aim to characterize those who convert to mild cognitive impairment or dementia during the follow-up, and further find the predicted factors associated with the progression of AD.
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ying Han
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cologne
- Responsible party
- Sponsor-investigator, Ying Han, Xuanwu Hospital, Beijing
- Investigators
- Ying Han, PhD, Principal investigator, Xuanwu Hospital of Capital Medical UniversityJessen Frank, PhD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696315
- Sponsor's protocol ID
- HanYingsc5
- Status last verified
- Aug 2026
- First submitted
- 3 Jan 2021
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The information of neuropsychological tests, neuroimaging data are to be shared with other researchers.
Publications
Shao K, Hu X, Kleineidam L, Stark M, Altenstein S, Amthauer H, Boecker H, Buchert R, Buerger K, Butryn M, Cai Y, Cai Y, Cosma NC, Chen G, Chen Z, Daamen M, Drzezga A, Duzel E, Essler M, Ewers M, Fliessbach K, Gaertner FC, Glanz W, Guo T, Hansen N, He B, Janowitz D, Kilimann I, Krause BJ, Lan G, Lange C, Laske C, Li Y, Li R, Liu L, Lu J, Meng F, Munk MH, Peters O, Perneczky R, Priller J, Ramirez A, Rauchmann BS, Reimold M, Rominger A, Rostamzadeh A, Roy-Kluth N, Schneider A, Spottke A, Spruth EJ, Sun P, Teipel S, Wang X, Wei M, Wei Y, Wiltfang J, Yan S, Yang J, Yu X, Zhang M, Zhang L; DELCODE study group, SILCODE study group; Wagner M, Jessen F, Han Y, Kuhn E. Amyloid and SCD jointly predict cognitive decline across Chinese and German cohorts. Alzheimers Dement. 2024 Sep;20(9):5926-5939. doi: 10.1002/alz.14119. Epub 2024 Jul 27.
PubMed 39072956Sheng C, Yang K, He B, Li T, Wang X, Du W, Hu X, Jiang J, Jiang X, Jessen F, Han Y. Cross-Cultural Longitudinal Study on Cognitive Decline (CLoCODE) for Subjective Cognitive Decline in China and Germany: A Protocol for Study Design. J Alzheimers Dis. 2022;87(3):1319-1333. doi: 10.3233/JAD-215452.
PubMed 35431240
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Subjective Cognitive Decline Between the German and Chinese and Early Diagnosis of Alzheimer's Disease Based on Radiogenomics
- ClinicalTrials.gov ID
- NCT04696315
- Acronym / sponsor ID
- HanYingsc5
- Conditions
- Alzheimer Disease, Subjective Cognitive Decline, Neuroimaging, Gene
- Keywords
- Subjective Cognitive Decline, Radiogenomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Ying HanUniversity, hospital or other
- Collaborators
- University of Cologne
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 6 Jan 2021 (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 incidence of AD dementia is increasing due to the aging population, putting a heavy burden on our society and economics. Exploring the mechanisms underlying SCD due to preclinical AD has scientific and clinical significance. However, it is challenging to construct and validate the preclinical diagnosis model of AD with fused multimodel information across culture/race. From the cooperation during the past five years, we have established cohorts by synchronized assessment, achieved consensus on SCD features extraction and made a breakthrough in the application of multiple parameter MRI with German collaborators. Therefore, in this project, SCD with and without amyloid pathology will be compared by clinical and cognitive data, genetics, blood and MRI biomarkers between the German and Chinese. Key features will be extracted and specific characteristics of SCD due to preclinical AD as well as risk factors for conversion between two countries will be clarified. Then the diagnosis model of preclinical AD in SCD will be established across culture/race based on radiogenomics, which will improve the current diagnostic system of AD. Through this project, the value of SCD in the etiologic, anatomical and quantitative diagnosis of preclinical AD will be identified to improve sensitivity and specificity of preclinical AD diagnosis in clinical practice.
Detailed description
The overall prevalence of dementia worldwide is increasing, imposing a heavy burden on the public and health care systems. Subjective cognitive decline (SCD), characterized by a self-report of decline in cognitive function without objective impairment in neuropsychological assessments, is considered a high risk factor for AD. SCD with amyloidopathy is considered as a first symptomatic indicator of the preclinical AD (SCD due to preclinical AD). However, how to construct and validate the preclinical diagnosis model of AD with fused multimodel information across culture/race remain unclear.
In the present study, all SCD participants from Germany and China will be conducted amyloid PET scanning, and they will be classified into two groups (SCD with amyloid+ and SCD with amyloid-) based on whether there is the evidence of amyloid deposition. The investigators will compare the clinical information, genetics, blood and multiple parameter MRI data between the German and Chinese to evaluate the common and specific features from different culture/race. Then, key features associated with amyloid deposition will be extracted for the establisment of diagnosis model of SCD due to preclinical AD, which will improve the current diagnostic system of AD. After four-year follow-up, SCD will be classified into SCD converter group and SCD non-converter group. Risk factors for conversion to cognitive impairment and dementia will be further extracted as predicted biomarkers.
Through this project, the value of SCD in the etiologic, anatomical and quantitative diagnosis of preclinical AD will be identified to improve sensitivity and specificity of preclinical AD diagnosis in clinical practice.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCD subjects with positive amyloid | – | Diagnostic Test: Multiple features extractionIn this study, the participants are from two research centers in China and Germany. All participants will conduct amyloid PET scanning, after which they are classified into two grous (SCD with amyloid+ and SCD with amyloid-). SCD subjects with positive amyloid show the evidence of amyloid deposition in brain. They have higher risk of conversion to mild cognitive impairment and dementia compared with SCD with negative amyloid. They are also considered as preclinical AD. |
| SCD subjects with negative amyloid | – | Diagnostic Test: Multiple features extractionIn this study, the participants are from two research centers in China and Germany. All participants will conduct amyloid PET scanning, after which they are classified into two grous (SCD with amyloid+ and SCD with amyloid-). SCD subjects with negative amyloid do not show the evidence of amyloid deposition in brain. They have lower risk of conversion to mild cognitive impairment and dementia compared with SCD with positive amyloid. |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- SCD may serve as a first symptomatic indicator during the preclinical stage of AD. SCD with amyloidopathy had a risk of progressing to AD dementia. In this study, all participants from two centers in Germany and China will be classified into two groups (SCD with amyloid+ and SCD with amyloid-) based on the amyloid PET. In addition, the participants will conduct multiple parameter MRI scanning, clinical data collection, blood biomarkers and gene examination. The investigators aim to reveal the common risk factors associated with amyloid deposition based on clinical, neuroimaging, and genetic information from two countries.
Key inclusion criteria (5 listed)
- 60-79 years old, right-handed and Mandarin-speaking subjects;
- self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event;
- normal age-, gender- and education-adjusted performance on standardised cognitive tests;
- concerns (worries) associated with memory complaint;
- failure to meet the criteria for MCI or dementia
Key exclusion criteria (6 listed)
- a history of stroke;
- major depression (Hamilton Depression Rating Scale score > 24 points);
- other central nervous system diseases that may cause cognitive impairment, such as Parkinson's disease, tumors, encephalitis and epilepsy;
- cognitive impairment caused by traumatic brain injury;
- systemic diseases, such as thyroid dysfunction, syphilis and HIV;
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 |
|---|---|---|
| Multiple features extractionIn the present study, the "gold standard" of preclinical AD is amyloid PET. SCD with positive amyloid is the target population for early AD intervention. The investigators aim to extract the diagnostic features from multiple parameter MRI, genetic, blood and clinical data using Max-Relevance and Min-Redundancy (mRMR) algorithm. Then, based on support vector machine (SVM), random forest (RF) and multi-kernel learning (MKL) classification methods, the investigators will construct predicted diagnostic model of preclinical AD. | Diagnostic test | SCD subjects with negative amyloid, SCD subjects with positive amyloid |
Primary outcome
Biomarkers associated with amyloid deposition
Time frame: Four years
SCD with the evidence of brain amyloid deposition is considered as preclinical AD. The investigators aim to extract multiple features involving neuroimaging, gene sequencing, blood, and clinical data to identify individuals with amyloid+ from SCD persons. These features associated with amyloid deposition are valuable biomarkers for early diagnosis of AD.
1 secondary outcome
Predicted biomarkers associated with conversion to cognitive impairment
Time frame: Four years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Derived from this study: PubMed 39072956Shao K, Hu X, Kleineidam L, Stark M, Altenstein S, Amthauer H, Boecker H, Buchert R, Buerger K, Butryn M, Cai Y, Cai Y, Cosma NC, Chen G, Chen Z, Daamen M, Drzezga A, Duzel E, Essler M, Ewers M, Fliessbach K, Gaertner FC, Glanz W, Guo T, Hansen N, He B, Janowitz D, Kilimann I, Krause BJ, Lan G, Lange C, Laske C, Li Y, Li R, Liu L, Lu J, Meng F, Munk MH, Peters O, Perneczky R, Priller J, Ramirez A, Rauchmann BS, Reimold M, Rominger A, Rostamzadeh A, Roy-Kluth N, Schneider A, Spottke A, Spruth EJ, Sun P, Teipel S, Wang X, Wei M, Wei Y, Wiltfang J, Yan S, Yang J, Yu X, Zhang M, Zhang L; DELCODE study group, SILCODE study group; Wagner M, Jessen F, Han Y, Kuhn E. Amyloid and SCD jointly predict cognitive decline across Chinese and German cohorts. Alzheimers Dement. 2024 Sep;20(9):5926-5939. doi: 10.1002/alz.14119. Epub 2024 Jul 27.
- Derived from this study: PubMed 35431240Sheng C, Yang K, He B, Li T, Wang X, Du W, Hu X, Jiang J, Jiang X, Jessen F, Han Y. Cross-Cultural Longitudinal Study on Cognitive Decline (CLoCODE) for Subjective Cognitive Decline in China and Germany: A Protocol for Study Design. J Alzheimers Dis. 2022;87(3):1319-1333. doi: 10.3233/JAD-215452.
- Individual participant dataSharing planned: Yes. The information of neuropsychological tests, neuroimaging data are to be shared with other researchers.
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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. This study is not recruiting at the moment.
Ying Han, PhD principal investigator
Xuanwu Hospital of Capital Medical University
Jessen Frank, PhD principal investigator
University of Cologne
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 Subjective Cognitive Decline, run by Ying Han 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 21 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers associated with amyloid deposition (time frame: Four years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04696315, which also lists 2 linked publications.
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 21 Aug 2026.