NCT03370744

Brief 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 construct a high-precision multi-modal model for early diagnosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

3.3 years

First QC Date

November 15, 2017

Last Update Submit

September 7, 2023

Conditions

Subjective Cognitive DeclinePreclinical Alzheimer's Disease

Keywords

subjective cognitive declinebrain networkmulti-modalitymagnetic resonance imaging

Outcome Measures

Primary Outcomes (8)

  • The altered volume pattern in SCD/SCD-plus with progression.

    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

    5 years

  • The altered DTI pattern in SCD/SCD-plus with progression.

    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.

    5 years

  • The altered functional MRI pattern in SCD/SCD-plus with progression.

    Resting state functional MRI blood-oxygen-level-dependent (fMRI BOLD) signal.

    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.

    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.

    5 years

  • Genotype of SCD/SCD-plus with progression.

    ApoE genotype by blood test.

    5 years

  • AD7c-NTP level of SCD/SCD-plus with progression.

    AD7c-NTP level by urine tests.

    5 years

  • Gut microbiota of SCD/SCD-plus with progression.

    Gut microbiota level by 16s rDNA sequencing

    5 years

Study Arms (5)

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.

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.

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.

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.

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.

Diagnostic Test: Neuropsychological scale

Interventions

Neuropsychological scaleDIAGNOSTIC_TEST

Neuropsychological scale, including mini-mental state examination (MMSE), Montreal cognitive assessment (MoCA), clinical dementia rating scales (CDR) and so on

Alzheimer's disease, ADMild cognitive impairment, MCINormal control, NCSubjective Cognitive Decline plus, SCD-plusSubjective cognitive decline, SCD

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Volunteers recrewed from communities, and signed up with informed consent.

You may qualify if:

  • Older than 60, right handedness, Han nationality;
  • Have no cognitive decline complains, with neither worry nor concern about their cognition;
  • Scores of standardized neuropsychological tests scale adjusted for age, sex and education are in normal range;
  • Physical examination is negative;
  • Review medical history and family history is negative, accessory examination don't show disease could cause cognitive decline;
  • Could cooperate collection of multi-modal magnetic resonance imaging, once a year, for continueously five years.
  • Presence of self-perceived continuous cognitive decline compared to previous normal status and unrelated to an acute event;
  • Failure to meet the following criteria for MCI.
  • Presence of self-perceived continuous cognitive decline compared to previous normal status and unrelated to an acute event;
  • Concerns (worries) associated with memory complaint;
  • Failure to meet the following criteria for MCI.
  • Clinical Dementia Rating (CDR) score of 0.5 as well as failure to meet the criteria for dementia
  • 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);
  • Having impaired scores in each of the three cognitive domains sampled;
  • the Functional Activities Questionnaire (FAQ) ≥9.

You may not qualify if:

  • Claustrophobia, with metals in the body that cannot be examined by MRI, including metal dentures or other contraindications for examination;
  • Left handedness or ambidextrality.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurolgy,Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (12)

  • Chen 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.

    PMID: 40053120DERIVED

  • Zhao 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.

    PMID: 39812690DERIVED

  • Yu 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.

    PMID: 39710611DERIVED

  • Wang 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.

    PMID: 37740923DERIVED

  • Wang 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.

    PMID: 37021284DERIVED

  • Wang 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.

    PMID: 35387811DERIVED

  • Sheng 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.

    PMID: 35164860DERIVED

  • Ding 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.

    PMID: 34291850DERIVED

  • Dong 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.

    PMID: 33827675DERIVED

  • Sheng 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.

    PMID: 32716355DERIVED

  • Li 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.

    PMID: 31350244DERIVED

  • Sun 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.

    PMID: 31159873DERIVED

Study Officials

  • Ying Han, Doctor

    Xuanwu Hospitial Capital Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Neurology, Professor

Study Record Dates

First Submitted

November 15, 2017

First Posted

December 12, 2017

Study Start

March 15, 2017

Primary Completion

June 30, 2020

Study Completion

December 31, 2022

Last Updated

September 8, 2023

Record last verified: 2023-09

Locations

CN(1)