- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03370744
Prediction of Cognitive Decline by Neuroimaging Techniques and the Application in Diagnosis and Treatment of Preclinical AD
September 7, 2023 updated by: XuanwuH 2
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ying Han, Doctor
- Phone Number: +86 13621011941
- Email: hanying@xwh.ccmu.edu.cn
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100053
- Department of Neurolgy,Xuanwu Hospital of Capital Medical University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Volunteers recrewed from communities, and signed up with informed consent.
Description
1. NC Inclusion Criteria:
- 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.
2. SCD Inclusion Criteria:
- 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.
3.SCD-plus Inclusion Criteria:
- 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.
3. MCI Inclusion Criteria:
- 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.
4. AD Inclusion Criteria 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.
Exclusion Criteria:
- Claustrophobia, with metals in the body that cannot be examined by MRI, including metal dentures or other contraindications for examination;
- Left handedness or ambidextrality.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Neuropsychological scale, including mini-mental state examination (MMSE), Montreal cognitive assessment (MoCA), clinical dementia rating scales (CDR) and so on
|
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.
|
Neuropsychological scale, including mini-mental state examination (MMSE), Montreal cognitive assessment (MoCA), clinical dementia rating scales (CDR) and so on
|
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.
|
Neuropsychological scale, including mini-mental state examination (MMSE), Montreal cognitive assessment (MoCA), clinical dementia rating scales (CDR) and so on
|
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.
|
Neuropsychological scale, including mini-mental state examination (MMSE), Montreal cognitive assessment (MoCA), clinical dementia rating scales (CDR) and so on
|
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.
|
Neuropsychological scale, including mini-mental state examination (MMSE), Montreal cognitive assessment (MoCA), clinical dementia rating scales (CDR) and so on
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The altered volume pattern in SCD/SCD-plus with progression.
Time Frame: 5 years
|
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5 years
|
The altered DTI pattern in SCD/SCD-plus with progression.
Time Frame: 5 years
|
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5 years
|
The altered functional MRI pattern in SCD/SCD-plus with progression.
Time Frame: 5 years
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Resting state functional MRI blood-oxygen-level-dependent (fMRI BOLD) signal.
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5 years
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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.
|
5 years
|
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.
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5 years
|
Genotype of SCD/SCD-plus with progression.
Time Frame: 5 years
|
ApoE genotype by blood test.
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5 years
|
AD7c-NTP level of SCD/SCD-plus with progression.
Time Frame: 5 years
|
AD7c-NTP level by urine tests.
|
5 years
|
Gut microbiota of SCD/SCD-plus with progression.
Time Frame: 5 years
|
Gut microbiota level by 16s rDNA sequencing
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5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ying Han, Doctor, Xuanwu Hospitial Capital Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2017
Primary Completion (Actual)
June 30, 2020
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
November 15, 2017
First Submitted That Met QC Criteria
December 11, 2017
First Posted (Actual)
December 12, 2017
Study Record Updates
Last Update Posted (Actual)
September 8, 2023
Last Update Submitted That Met QC Criteria
September 7, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- hanying4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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