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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03370744
Other study ID # hanying4
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2017
Est. completion date December 31, 2022

Study information

Verified date September 2023
Source Xuanwu Hospital, Beijing
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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


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


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date December 31, 2022
Est. primary completion date June 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 80 Years
Eligibility 1. NC Inclusion Criteria: 1. Older than 60, right handedness, Han nationality; 2. Have no cognitive decline complains, with neither worry nor concern about their cognition; 3. Scores of standardized neuropsychological tests scale adjusted for age, sex and education are in normal range; 4. Physical examination is negative; 5. Review medical history and family history is negative, accessory examination don't show disease could cause cognitive decline; 6. Could cooperate collection of multi-modal magnetic resonance imaging, once a year, for continueously five years. 2. SCD Inclusion Criteria: 1. Presence of self-perceived continuous cognitive decline compared to previous normal status and unrelated to an acute event; 2. Failure to meet the following criteria for MCI. 3.SCD-plus Inclusion Criteria: 1. Presence of self-perceived continuous cognitive decline compared to previous normal status and unrelated to an acute event; 2. Concerns (worries) associated with memory complaint; 3. Failure to meet the following criteria for MCI. 3. MCI Inclusion Criteria: 1. Clinical Dementia Rating (CDR) score of 0.5 as well as failure to meet the criteria for dementia 2. 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); 3. Having impaired scores in each of the three cognitive domains sampled; 4. 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: 1. Claustrophobia, with metals in the body that cannot be examined by MRI, including metal dentures or other contraindications for examination; 2. Left handedness or ambidextrality.

Study Design


Intervention

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

Locations

Country Name City State
China Department of Neurolgy,Xuanwu Hospital of Capital Medical University Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
XuanwuH 2

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
5 years
Primary 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.
5 years
Primary The altered functional MRI pattern in SCD/SCD-plus with progression. Resting state functional MRI blood-oxygen-level-dependent (fMRI BOLD) signal. 5 years
Primary 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
Primary 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
Primary Genotype of SCD/SCD-plus with progression. ApoE genotype by blood test. 5 years
Primary AD7c-NTP level of SCD/SCD-plus with progression. AD7c-NTP level by urine tests. 5 years
Primary Gut microbiota of SCD/SCD-plus with progression. Gut microbiota level by 16s rDNA sequencing 5 years
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