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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Department of Neurolgy,Xuanwu Hospital of Capital Medical University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  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 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Diagnostic test: Neuropsychological scale
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.
Diagnostic test: Neuropsychological scale
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.
Diagnostic test: Neuropsychological scale
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.
Diagnostic test: Neuropsychological scale
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
5 years
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.
5 years
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.
5 years
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.
5 years
Genotype of SCD/SCD-plus with progression.
Time Frame: 5 years
ApoE genotype by blood test.
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
XuanwuH 2

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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