China Longitudinal Aging and Cognitive Impairment Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-99
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
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.
Eligibility criteria
Qualifiers
Cognitive normal aging (CN) 1. 40 years and older , without cognitive impairment, MMSE≥22 2. 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) 1. 40 years and older 2. Diagnosis according to 2004 Peterson's MCI criteria. 3. Clinical Dementia Rating (CDR) = 0.5. 4. Memory loss is prominent, and may also be with other cognitive domain impairment.
Alzheimer's disease (AD)
Disqualifiers
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
Trial design
Treatments tested in this trial
- None of intervention
Treatment groups
4,000 Participants
are divided into 5 treatment groupsSponsors and collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
The Central Hospital of Lishui City
Collaborator
Zhejiang Rehabilitation Center
Collaborator
Source ClinicalTrials.gov