China Longitudinal Aging and Cognitive Impairment Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aging
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 4000
- Locations
- 2
- Primary Endpoint
- The imaging biomarkers for normal aging, MCI and AD diagnosis
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a multi-center longitudinal study that consists of five cohorts: cognitive normal aging (CN), Subjective cognitive impairment (SCI), mild cognitive impairment (MCI), Alzheimer's disease (AD) and vascular cognitive impairment (VCI). The goals of this study are as follow: 1.To establish longitudinal cohort study database containing comprehensive epidemiological data, neuropsychological test data, laboratory parameters, image data and biological samples. 2. To determine the risk factors of AD and other dementias. 3. To explore the conversion rates from CN to SCI, MCI or AD and the risk factors as well as biomarkers for the progression from CN to SCI, MCI or AD. 4. To explore and validate blood, CSF, urine, imaging and other biomarkers for the early detection and progression of AD.
Detailed Description
As the population ages in China, the number of patients with neurocognitive disorders such as Alzheimer's disease (AD) and vascular cognitive impairment (VCI) is steadily increasing. The burden of cognitive impairment in China has been an important public health problem. Cohort study on aging and cognitive impairment is urgent to better understand and address this issue. Early prevention, diagnosis and treatment are critical for reduction the burden of cognitive impairment. In this prospective study, subjects will be recruited into one of the five groups based on inclusion and exclusion criteria: 1) CN, 2) MCI 3) AD and 4) VCI. Each of the subjects will be followed up at designated time points up to 5 years. Epidemiological data, medical, imaging (MRI and PET scans), genetic information and various biological samples will be collected during the baseline and follow-up period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •Cognitive normal aging (CN)
- •40 years and older , without cognitive impairment, MMSE≥22
- •Informed consent is signed by the participant
- •Subjective cognitive impairment (SCI) Participants aged 40 and older, with absence of dementia (by DSM IV and DSM V) criteria. Normal age-, sex-, and education-adjusted performance on standardized cognitive tests, which are used to classify mild cognitive impairment (MCI) or prodromal AD. Self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event. Answering "yes" to both of the following questions: "Do you feel like your memory or thinking is becoming worse?" and "Does this concern you?"
- •Mild cognitive impairment (MCI)
- •40 years and older
- •Diagnosis according to 2004 Peterson's MCI criteria.
- •Clinical Dementia Rating (CDR) = 0.
- •Memory loss is prominent, and may also be with other cognitive domain impairment.
Exclusion Criteria
- •Cognitive normal aging (CN)
- •any disease that can cause cognitive impairment (such as Alzheimer's disease, dementia with Lewy bodies (DLB), frontotemporal dementia (FTLD), Parkinson's disease dementia (PDD), intracranial masses that impair cognition, history of severe brain trauma, normal pressure hydrocephalus, cerebrovascular disease with obvious clinical symptoms, etc.
- •sequelae after previous history of severe central nervous system infection, multiple sclerosis, autoimmune encephalitis, Hashimoto's encephalopathy, etc.
- •previous history of instable epilepsy
- •systemic diseases affect the central nervous system, for abnormal liver and kidney functions (abdominal dialysis, hemodialysis, AST≥3× upper limit of normal value (ULN), ALT≥3× upper limit of normal value (ULN) or total bilirubin ≥2×ULN
- •history of hereditary diseases that affect cognitive function (such as Huntington's disease, down syndrome, CADASIL, adrenal leukodystrophy, mitochondrial encephalopathy, etc.)
- •long-term heavy drinking history (alcohol content more than 42 degree liquor, more than 150g/day, alcohol consumption more than 12 months)
- •history of severe pulmonary diseases (COPD, pulmonary encephalopathy)
- •history of serious cardiovascular disease (heart failure, severe hypertension)
- •infection and immune-related diseases affecting the central nervous system (systemic lupus erythematosus, undertreated HIV infection or a history of CNS syphilis infection, etc.)
Outcomes
Primary Outcomes
The imaging biomarkers for normal aging, MCI and AD diagnosis
Time Frame: 5 years
Imaging biomarkers included cerebral atrophy, amyloid and tau deposition of whole brain or hippocampus, glucose metabolism and other novel biomarkers.
Gait
Time Frame: 5 years
Gait characteristics such as stride-to-stride variability of stride time, and gait speed were evaluated by 3D gait detection.
Gut microbiota
Time Frame: 5 years
Fecal microbiome will be analyzed by 16S rRNA gene sequencing and metagenome sequencing.
Prevalence, incidence of cognitive impairment caused by neurological disease such as AD, VCI and other types of dementia
Time Frame: 5 years
All of the participants will be evaluated by cognitive assessment scale annually.
The conversion rate of normal aging to SCI, MCI and AD
Time Frame: 5 years
All of the participants will be evaluated by cognitive assessment scale annually.
The fluid biomarkers for normal aging, SCI, MCI and AD diagnosis
Time Frame: 5 years
Cerebrospinal fluid, plasma, saliva and urine biomarkers included Aβ42, Aβ40, phosphated tau and total tau, and other novel biomarkers.