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Clinical Trials/NCT03370744
NCT03370744
Completed
N/A

Prediction of Cognitive Decline by Neuroimaging Techniques and the Application in Diagnosis and Treatment of Preclinical AD (Sino Longitudinal Study on Cognitive Decline, SILCODE)

XuanwuH 21 site in 1 country300 target enrollmentMarch 15, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Subjective Cognitive Decline
Sponsor
XuanwuH 2
Enrollment
300
Locations
1
Primary Endpoint
The altered volume pattern in SCD/SCD-plus with progression.
Status
Completed
Last Updated
2 years ago

Overview

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.

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

Registry
clinicaltrials.gov
Start Date
March 15, 2017
End Date
December 31, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
XuanwuH 2
Responsible Party
Sponsor Investigator
Principal Investigator

XuanwuH 2

Director of Neurology, Professor

Xuanwu Hospital, Beijing

Eligibility Criteria

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.
  • 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:

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.

Outcomes

Primary Outcomes

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 functional MRI pattern in SCD/SCD-plus with progression.

Time Frame: 5 years

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

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.

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.

Gut microbiota of SCD/SCD-plus with progression.

Time Frame: 5 years

Gut microbiota level by 16s rDNA sequencing

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 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.

Study Sites (1)

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