Subjective Cognitive DeclineNCT03370744
Prediction of Cognitive Decline by Neuroimaging Techniques and the Application in Diagnosis and Treatment of Preclinical AD
An observational study of Subjective Cognitive Decline and Preclinical Alzheimer's Disease, run by XuanwuH 2 at 1 site in China.
Trial summary
This study is affiliated to Sino Longitudinal Study on Cognitive Decline, SILCODE. To establish models of normal and pathological cognitive aging.To collect the longitudinal data of SCD population, to study the dynamic changes of brain networks so as to explore the progressive mechanisms of AD on brain networks and to… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjective Cognitive Decline, Preclinical Alzheimer's Disease
- What is being tested?
- Neuropsychological scale
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2017to 31 Dec 2022
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers recrewed from communities, and signed up with informed consent.
Who may be able to join
None listed.
Who cannot join
- Claustrophobia, with metals in the body that cannot be examined by MRI, including metal dentures or other contraindications for examination;
- Left handedness or ambidextrality.
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: Prediction of Cognitive Decline by Neuroimaging Techniques and the Application in Diagnosis and Treatment of Preclinical AD (Sino Longitudinal Study on Cognitive Decline, SILCODE)
This study is affiliated to Sino Longitudinal Study on Cognitive Decline, SILCODE. To establish models of normal and pathological cognitive aging.To collect the longitudinal data of SCD population, to study the dynamic changes of brain networks so as to explore the progressive mechanisms of AD on brain networks and to construct a high-precision multi-modal model for early diagnosis.
Read the detailed description
This study is affiliated to Sino Longitudinal Study on Cognitive Decline, SILCODE. Alzheimer's disease (AD) is the most common cause of dementia, which severely injures multiple domains of cognitive functions in the aging people, bringing heavy burden to the society and families. Studying the cognitive brain damage mechanism of subjective cognitive decline (SCD), the preclinical stage of AD, would provide great opportunities for understanding the pathogenesis of AD and clinical value for early diagnosis and intervention in AD. The project intends to utilize amyloid-PET and FDG-PET for screening and then employ the comprehensive neuropsychological examination combined with multi-modal MRI neuroimaging techniques to study the brain functions and structures of the normal aging and SCD. The imaging data would be analyzed from several levels, including the cognitive dimensions, brain activation patterns, and especially functional and structural networks to establish the models of normal and pathological cognitive aging, which mainly be modulated by frontal-parietal control system. We aim to establish models of normal and pathological cognitive aging. Furthermore, the longitudinal data of SCD population would be collected to study the dynamic changes of brain networks so as to explore the progressive mechanisms of AD on brain networks and to construct a high-precision multi-modal model for early diagnosis
- Being tested
- Neuropsychological scale
- Keywords
- subjective cognitive decline, brain network, multi-modality, magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological scaleDiagnostic test
Neuropsychological scale, including mini-mental state examination (MMSE), Montreal cognitive assessment (MoCA), clinical dementia rating scales (CDR) and so on
| Study group | Role | What they receive |
|---|---|---|
| Subjective cognitive decline, SCD | The inclusion criteria for SCD are as following: (1) presence of self-perceived continuous cognitive decline compared to previous normal status and unrelated to an acute event; and (2) failure to meet the following criteria for MCI. Receives: Diagnostic Test: Neuropsychological scale | |
| Normal control, NC | NC are individuals who have no self-report persistent decline in cognitive capacity, and with neither worry nor concern about their cognition. Without measurable cognitive impairment according to results of standard assessments. Receives: Diagnostic Test: Neuropsychological scale | |
| Mild cognitive impairment, MCI | MCI are defined by an actuarial neuropsychological method proposed by Jak and Bondi. Participants are considered to have MCI if any one of the following three criteria are met with a total Clinical Dementia Rating (CDR) score of 0.5 as well as failure to meet the criteria for dementia: (1) having impaired scores (defined as >1 SD below the age-corrected normative mean) on both measures within at least one cognitive domain (i.e., memory, language, or speed/executive function); (2) having impaired scores in each of the three cognitive domains sampled; (3) the Functional Activities Questionnaire (FAQ) ≥9. Receives: Diagnostic Test: Neuropsychological scale | |
| Alzheimer's disease, AD | The diagnosis of AD syndrome is based on the diagnostic guidelines for dementia due to AD delivered by the National Institute on Aging-Alzheimer's Association workgroups (NIA-AA) with a total CDR score of 1. Receives: Diagnostic Test: Neuropsychological scale | |
| Subjective Cognitive Decline plus, SCD-plus | The inclusion criteria for SCD-plus are as following: (1) presence of self-perceived continuous cognitive decline compared to previous normal status and unrelated to an acute event; and (2) concerns (worries) associated with memory complaint; and (3) failure to meet the following criteria for MCI. Receives: Diagnostic Test: Neuropsychological scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
The altered volume pattern in SCD/SCD-plus with progression.
- Global grey matter volume change of brain in µm3
- Regional gray matter volume change of brain in µm3
- Cerebral cortex thickness change of brain in µm
Measured: 5 years
The altered DTI pattern in SCD/SCD-plus with progression.
- Regional fractional anisotropy (FA), measured by diffusion tensor imaging (DTI).
- Regional mean diffusivity (MD), measured by DTI.
- Regional radial diffusivity (RD), measured by DTI.
- Regional axial diffusivity (AxD), measured by DTI.
Measured: 5 years
The altered functional MRI pattern in SCD/SCD-plus with progression.
Resting state functional MRI blood-oxygen-level-dependent (fMRI BOLD) signal.
Measured: 5 years
The altered FDG-PET pattern in SCD/SCD-plus with progression.
Global SUVR change of brain of FDG-PET in kBq/ml/MBq/kg.
Measured: 5 years
The altered AV45-PET pattern in SCD/SCD-plus with progression.
Global SUVR change of brain of AV45-PET in kBq/ml/MBq/kg.
Measured: 5 years
Genotype of SCD/SCD-plus with progression.
ApoE genotype by blood test.
Measured: 5 years
AD7c-NTP level of SCD/SCD-plus with progression.
AD7c-NTP level by urine tests.
Measured: 5 years
Gut microbiota of SCD/SCD-plus with progression.
Gut microbiota level by 16s rDNA sequencing
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start15 Mar 2017
- Primary completion30 Jun 2020
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Subjective Cognitive DeclineStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- XuanwuH 2
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, XuanwuH 2, Xuanwu Hospital, Beijing
- Investigators
- Ying Han, Doctor, Study chair, Xuanwu Hospitial Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370744
- Sponsor's protocol ID
- hanying4
- Status last verified
- Sep 2023
- First submitted
- 15 Nov 2017
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jiang X, Zhang M, Yan C, Daamen M, Boecker H, Yue F, Jessen F, Hu X, Han Y. Brain Topological Changes in Subjective Cognitive Decline and Associations with Amyloid Stages. J Neurosci. 2025 Jun 18;45(25):e2310242025. doi: 10.1523/JNEUROSCI.2310-24.2025.
PubMed 40404356Chen HJ, Zhang M, Wei M, Yu X, Wang Y, Yang J, Li R, Zhao W, Wang X, Zhang S, Wang K, Bai T, Huo Y, Huang W, Dai Z, Ma G, Han Y, Chen G, Shu N. Amyloid pathology related to aberrant structure-function coupling of brain networks in Alzheimer's disease: insights from [18F]-florbetapir PET imaging. Eur J Nucl Med Mol Imaging. 2025 Jul;52(8):2929-2940. doi: 10.1007/s00259-025-07172-8. Epub 2025 Mar 7.
PubMed 40053120Zhao C, Li T, Hao S, Zhao L, Han Y, Cai Y. Dysregulation of the molecular clock by blood-borne factors in Alzheimer's disease patients. J Neurol. 2025 Jan 15;272(2):121. doi: 10.1007/s00415-024-12824-0.
PubMed 39812690Yu X, Zhang Y, Cai Y, Rong N, Li R, Shi R, Wei M, Jiang J, Han Y. Asymmetrical patterns of beta-amyloid deposition and cognitive changes in Alzheimer's disease: the SILCODE study. Cereb Cortex. 2024 Dec 3;34(12):bhae485. doi: 10.1093/cercor/bhae485.
PubMed 39710611Wang L, Xu H, Wang M, Brendel M, Rominger A, Shi K, Han Y, Jiang J. A metabolism-functional connectome sparse coupling method to reveal imaging markers for Alzheimer's disease based on simultaneous PET/MRI scans. Hum Brain Mapp. 2023 Dec 1;44(17):6020-6030. doi: 10.1002/hbm.26493. Epub 2023 Sep 23.
PubMed 37740923Wang T, Yao Y, Han C, Li T, Du W, Xue J, Han Y, Cai Y. MCP-1 levels in astrocyte-derived exosomes are changed in preclinical stage of Alzheimer's disease. Front Neurol. 2023 Mar 20;14:1119298. doi: 10.3389/fneur.2023.1119298. eCollection 2023.
PubMed 37021284Wang T, Wang X, Yao Y, Zhao C, Yang C, Han Y, Cai Y. Association of plasma apolipoproteins and levels of inflammation-related factors with different stages of Alzheimer's disease: a cross-sectional study. BMJ Open. 2022 Apr 6;12(4):e054347. doi: 10.1136/bmjopen-2021-054347.
PubMed 35387811Sheng C, Yang K, He B, Du W, Cai Y, Han Y. Combination of gut microbiota and plasma amyloid-beta as a potential index for identifying preclinical Alzheimer's disease: a cross-sectional analysis from the SILCODE study. Alzheimers Res Ther. 2022 Feb 14;14(1):35. doi: 10.1186/s13195-022-00977-x.
PubMed 35164860Ding C, Du W, Zhang Q, Wang L, Han Y, Jiang J. Coupling relationship between glucose and oxygen metabolisms to differentiate preclinical Alzheimer's disease and normal individuals. Hum Brain Mapp. 2021 Oct 15;42(15):5051-5062. doi: 10.1002/hbm.25599. Epub 2021 Jul 22.
PubMed 34291850Dong QY, Li TR, Jiang XY, Wang XN, Han Y, Jiang JH. Glucose metabolism in the right middle temporal gyrus could be a potential biomarker for subjective cognitive decline: a study of a Han population. Alzheimers Res Ther. 2021 Apr 7;13(1):74. doi: 10.1186/s13195-021-00811-w.
PubMed 33827675Sheng C, Sun Y, Wang M, Wang X, Liu Y, Pang D, Liu J, Bi X, Du W, Zhao M, Li Y, Li X, Jiang J, Han Y. Combining Visual Rating Scales for Medial Temporal Lobe Atrophy and Posterior Atrophy to Identify Amnestic Mild Cognitive Impairment from Cognitively Normal Older Adults: Evidence Based on Two Cohorts. J Alzheimers Dis. 2020;77(1):323-337. doi: 10.3233/JAD-200016.
PubMed 32716355Li X, Wang X, Su L, Hu X, Han Y. Sino Longitudinal Study on Cognitive Decline (SILCODE): protocol for a Chinese longitudinal observational study to develop risk prediction models of conversion to mild cognitive impairment in individuals with subjective cognitive decline. BMJ Open. 2019 Jul 26;9(7):e028188. doi: 10.1136/bmjopen-2018-028188.
PubMed 31350244Sun Y, Wang X, Wang Y, Dong H, Lu J, Scheininger T, Ewers M, Jessen F, Zuo XN, Han Y. Anxiety correlates with cortical surface area in subjective cognitive decline: APOE epsilon4 carriers versus APOE epsilon4 non-carriers. Alzheimers Res Ther. 2019 Jun 3;11(1):50. doi: 10.1186/s13195-019-0505-0.
PubMed 31159873
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Cognitive Decline by Neuroimaging Techniques and the Application in Diagnosis and Treatment of Preclinical AD (Sino Longitudinal Study on Cognitive Decline, SILCODE)
- ClinicalTrials.gov ID
- NCT03370744
- Acronym / sponsor ID
- hanying4
- Keywords
- subjective cognitive decline, brain network, multi-modality, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- XuanwuH 2University, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 12 Dec 2017 (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.
This study is affiliated to Sino Longitudinal Study on Cognitive Decline, SILCODE. To establish models of normal and pathological cognitive aging.To collect the longitudinal data of SCD population, to study the dynamic changes of brain networks so as to explore the progressive mechanisms of AD on brain networks and to construct a high-precision multi-modal model for early diagnosis.
Detailed description
This study is affiliated to Sino Longitudinal Study on Cognitive Decline, SILCODE. Alzheimer's disease (AD) is the most common cause of dementia, which severely injures multiple domains of cognitive functions in the aging people, bringing heavy burden to the society and families. Studying the cognitive brain damage mechanism of subjective cognitive decline (SCD), the preclinical stage of AD, would provide great opportunities for understanding the pathogenesis of AD and clinical value for early diagnosis and intervention in AD. The project intends to utilize amyloid-PET and FDG-PET for screening and then employ the comprehensive neuropsychological examination combined with multi-modal MRI neuroimaging techniques to study the brain functions and structures of the normal aging and SCD. The imaging data would be analyzed from several levels, including the cognitive dimensions, brain activation patterns, and especially functional and structural networks to establish the models of normal and pathological cognitive aging, which mainly be modulated by frontal-parietal control system. We aim to establish models of normal and pathological cognitive aging. Furthermore, the longitudinal data of SCD population would be collected to study the dynamic changes of brain networks so as to explore the progressive mechanisms of AD on brain networks and to construct a high-precision multi-modal model for early diagnosis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Subjective cognitive decline, SCD | – | Diagnostic Test: Neuropsychological scaleThe inclusion criteria for SCD are as following: (1) presence of self-perceived continuous cognitive decline compared to previous normal status and unrelated to an acute event; and (2) failure to meet the following criteria for MCI. |
| Normal control, NC | – | Diagnostic Test: Neuropsychological scaleNC are individuals who have no self-report persistent decline in cognitive capacity, and with neither worry nor concern about their cognition. Without measurable cognitive impairment according to results of standard assessments. |
| Mild cognitive impairment, MCI | – | Diagnostic Test: Neuropsychological scaleMCI are defined by an actuarial neuropsychological method proposed by Jak and Bondi. Participants are considered to have MCI if any one of the following three criteria are met with a total Clinical Dementia Rating (CDR) score of 0.5 as well as failure to meet the criteria for dementia: (1) having impaired scores (defined as >1 SD below the age-corrected normative mean) on both measures within at least one cognitive domain (i.e., memory, language, or speed/executive function); (2) having impaired scores in each of the three cognitive domains sampled; (3) the Functional Activities Questionnaire (FAQ) ≥9. |
| Alzheimer's disease, AD | – | Diagnostic Test: Neuropsychological scaleThe diagnosis of AD syndrome is based on the diagnostic guidelines for dementia due to AD delivered by the National Institute on Aging-Alzheimer's Association workgroups (NIA-AA) with a total CDR score of 1. |
| Subjective Cognitive Decline plus, SCD-plus | – | Diagnostic Test: Neuropsychological scaleThe inclusion criteria for SCD-plus are as following: (1) presence of self-perceived continuous cognitive decline compared to previous normal status and unrelated to an acute event; and (2) concerns (worries) associated with memory complaint; and (3) failure to meet the following criteria for MCI. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers recrewed from communities, and signed up with informed consent.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Claustrophobia, with metals in the body that cannot be examined by MRI, including metal dentures or other contraindications for examination;
- Left handedness or ambidextrality.
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 |
|---|---|---|
| Neuropsychological scaleNeuropsychological scale, including mini-mental state examination (MMSE), Montreal cognitive assessment (MoCA), clinical dementia rating scales (CDR) and so on | Diagnostic test | Alzheimer's disease, AD, Mild cognitive impairment, MCI, Normal control, NC, Subjective Cognitive Decline plus, SCD-plus, Subjective cognitive decline, SCD |
Primary outcome
The altered volume pattern in SCD/SCD-plus with progression.
Time frame: 5 years
1. Global grey matter volume change of brain in µm3 2. Regional gray matter volume change of brain in µm3 3. Cerebral cortex thickness change of brain in µm
The altered DTI pattern in SCD/SCD-plus with progression.
Time frame: 5 years
1. Regional fractional anisotropy (FA), measured by diffusion tensor imaging (DTI). 2. Regional mean diffusivity (MD), measured by DTI. 3. Regional radial diffusivity (RD), measured by DTI. 4. Regional axial diffusivity (AxD), measured by DTI.
The altered functional MRI pattern in SCD/SCD-plus with progression.
Time frame: 5 years
Resting state functional MRI blood-oxygen-level-dependent (fMRI BOLD) signal.
The altered FDG-PET pattern in SCD/SCD-plus with progression.
Time frame: 5 years
Global SUVR change of brain of FDG-PET in kBq/ml/MBq/kg.
The altered AV45-PET pattern in SCD/SCD-plus with progression.
Time frame: 5 years
Global SUVR change of brain of AV45-PET in kBq/ml/MBq/kg.
Genotype of SCD/SCD-plus with progression.
Time frame: 5 years
ApoE genotype by blood test.
AD7c-NTP level of SCD/SCD-plus with progression.
Time frame: 5 years
AD7c-NTP level by urine tests.
Gut microbiota of SCD/SCD-plus with progression.
Time frame: 5 years
Gut microbiota level by 16s rDNA sequencing
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 8 Sep 2023.
- Derived from this study: PubMed 40404356Jiang X, Zhang M, Yan C, Daamen M, Boecker H, Yue F, Jessen F, Hu X, Han Y. Brain Topological Changes in Subjective Cognitive Decline and Associations with Amyloid Stages. J Neurosci. 2025 Jun 18;45(25):e2310242025. doi: 10.1523/JNEUROSCI.2310-24.2025.
- Derived from this study: PubMed 40053120Chen HJ, Zhang M, Wei M, Yu X, Wang Y, Yang J, Li R, Zhao W, Wang X, Zhang S, Wang K, Bai T, Huo Y, Huang W, Dai Z, Ma G, Han Y, Chen G, Shu N. Amyloid pathology related to aberrant structure-function coupling of brain networks in Alzheimer's disease: insights from [18F]-florbetapir PET imaging. Eur J Nucl Med Mol Imaging. 2025 Jul;52(8):2929-2940. doi: 10.1007/s00259-025-07172-8. Epub 2025 Mar 7.
- Derived from this study: PubMed 39812690Zhao C, Li T, Hao S, Zhao L, Han Y, Cai Y. Dysregulation of the molecular clock by blood-borne factors in Alzheimer's disease patients. J Neurol. 2025 Jan 15;272(2):121. doi: 10.1007/s00415-024-12824-0.
- Derived from this study: PubMed 39710611Yu X, Zhang Y, Cai Y, Rong N, Li R, Shi R, Wei M, Jiang J, Han Y. Asymmetrical patterns of beta-amyloid deposition and cognitive changes in Alzheimer's disease: the SILCODE study. Cereb Cortex. 2024 Dec 3;34(12):bhae485. doi: 10.1093/cercor/bhae485.
- Derived from this study: PubMed 37740923Wang L, Xu H, Wang M, Brendel M, Rominger A, Shi K, Han Y, Jiang J. A metabolism-functional connectome sparse coupling method to reveal imaging markers for Alzheimer's disease based on simultaneous PET/MRI scans. Hum Brain Mapp. 2023 Dec 1;44(17):6020-6030. doi: 10.1002/hbm.26493. Epub 2023 Sep 23.
- Derived from this study: PubMed 37021284Wang T, Yao Y, Han C, Li T, Du W, Xue J, Han Y, Cai Y. MCP-1 levels in astrocyte-derived exosomes are changed in preclinical stage of Alzheimer's disease. Front Neurol. 2023 Mar 20;14:1119298. doi: 10.3389/fneur.2023.1119298. eCollection 2023.
- Derived from this study: PubMed 35387811Wang T, Wang X, Yao Y, Zhao C, Yang C, Han Y, Cai Y. Association of plasma apolipoproteins and levels of inflammation-related factors with different stages of Alzheimer's disease: a cross-sectional study. BMJ Open. 2022 Apr 6;12(4):e054347. doi: 10.1136/bmjopen-2021-054347.
- Derived from this study: PubMed 35164860Sheng C, Yang K, He B, Du W, Cai Y, Han Y. Combination of gut microbiota and plasma amyloid-beta as a potential index for identifying preclinical Alzheimer's disease: a cross-sectional analysis from the SILCODE study. Alzheimers Res Ther. 2022 Feb 14;14(1):35. doi: 10.1186/s13195-022-00977-x.
- Derived from this study: PubMed 34291850Ding C, Du W, Zhang Q, Wang L, Han Y, Jiang J. Coupling relationship between glucose and oxygen metabolisms to differentiate preclinical Alzheimer's disease and normal individuals. Hum Brain Mapp. 2021 Oct 15;42(15):5051-5062. doi: 10.1002/hbm.25599. Epub 2021 Jul 22.
- Derived from this study: PubMed 33827675Dong QY, Li TR, Jiang XY, Wang XN, Han Y, Jiang JH. Glucose metabolism in the right middle temporal gyrus could be a potential biomarker for subjective cognitive decline: a study of a Han population. Alzheimers Res Ther. 2021 Apr 7;13(1):74. doi: 10.1186/s13195-021-00811-w.
- Derived from this study: PubMed 32716355Sheng C, Sun Y, Wang M, Wang X, Liu Y, Pang D, Liu J, Bi X, Du W, Zhao M, Li Y, Li X, Jiang J, Han Y. Combining Visual Rating Scales for Medial Temporal Lobe Atrophy and Posterior Atrophy to Identify Amnestic Mild Cognitive Impairment from Cognitively Normal Older Adults: Evidence Based on Two Cohorts. J Alzheimers Dis. 2020;77(1):323-337. doi: 10.3233/JAD-200016.
- Derived from this study: PubMed 31350244Li X, Wang X, Su L, Hu X, Han Y. Sino Longitudinal Study on Cognitive Decline (SILCODE): protocol for a Chinese longitudinal observational study to develop risk prediction models of conversion to mild cognitive impairment in individuals with subjective cognitive decline. BMJ Open. 2019 Jul 26;9(7):e028188. doi: 10.1136/bmjopen-2018-028188.
- Individual participant dataSharing planned: Undecided
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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, Doctor study chair
Xuanwu Hospitial Capital Medical University
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 Subjective Cognitive Decline and Preclinical Alzheimer's Disease, run by XuanwuH 2 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 0 inclusion and 2 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 8 Sep 2023. 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?
The altered volume pattern in SCD/SCD-plus with progression. (time frame: 5 years). The study lists 8 primary outcomes in all. 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 NCT03370744, which also lists 13 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 8 Sep 2023.