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

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ClinicalTrials.gov Identifier: NCT03370744
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
XuanwuH 2, Xuanwu Hospital, Beijing

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.

Condition or disease Intervention/treatment
Subjective Cognitive Decline Preclinical Alzheimer's Disease Diagnostic Test: Neuropsychological scale

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

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prediction of Cognitive Decline by Neuroimaging Techniques and the Application in Diagnosis and Treatment of Preclinical AD (Sino Longitudinal Study on Cognitive Decline, SILCODE)
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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.
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




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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. 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.

  6. Genotype of SCD/SCD-plus with progression. [ Time Frame: 5 years ]
    ApoE genotype by blood test.

  7. AD7c-NTP level of SCD/SCD-plus with progression. [ Time Frame: 5 years ]
    AD7c-NTP level by urine tests.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Volunteers recrewed from communities, and signed up with informed consent.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370744


Contacts
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Contact: Ying Han, Doctor +86 13621011941 13621011941@163.com

Locations
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China, Beijing
Department of Neurolgy,Xuanwu Hospital of Capital Medical University Recruiting
Beijing, Beijing, China, 100053
Contact: Ying Han    +86 13621011941    13621011941@163.com   
Sponsors and Collaborators
XuanwuH 2
Investigators
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Study Chair: Ying Han, Doctor Xuanwu Hospitial Capital Medical University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: XuanwuH 2, Director of Neurology, Professor, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03370744    
Other Study ID Numbers: hanying4
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by XuanwuH 2, Xuanwu Hospital, Beijing:
subjective cognitive decline
brain network
multi-modality
magnetic resonance imaging
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders