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

Subjective Cognitive Decline Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03370744
• Other study ID #: hanying4
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Preclinical Alzheimer's Disease
• Subjective Cognitive Decline

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