Prediction of Cognitive Decline by Neuroimaging Techniques and the Application in Diagnosis and Treatment of Preclinical AD

NCT ID: NCT03370744

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-15
• Study Completion Date: 2022-12-31

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

Conditions

Subjective Cognitive Decline; Preclinical Alzheimer's Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Neuropsychological scale

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

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.

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.

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.

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

XuanwuH 2

OTHER

Sponsor Role: lead

Responsible Party

XuanwuH 2

Director of Neurology, Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ying Han, Doctor

Role: STUDY_CHAIR

Xuanwu Hospitial Capital Medical University

Locations

Department of Neurolgy,Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

References

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Other Identifiers

hanying4

Identifier Type: -

Identifier Source: org_study_id