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)
NCT number | NCT03370744 |
Other study ID # | hanying4 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 15, 2017 |
Est. completion date | December 31, 2022 |
Verified date | September 2023 |
Source | Xuanwu Hospital, Beijing |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Department of Neurolgy,Xuanwu Hospital of Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
XuanwuH 2 |
China,
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 |
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