Health TrialsbyHealthPanel

China Longitudinal Aging and Cognitive Impairment Study

ConditionsAgingMild Cognitive ImpairmentAlzheimer DiseaseNeurodegeneration
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

This trial accepts healthy volunteers

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 population

Male or female participants ages 40 to 99 years

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • None of intervention

    Other intervention

    None of intervention

Treatment groups

4,000 Participants
are divided into 5 treatment groups
Group A: Cognitive normal Aging (CN)1 intervention
Group B: Subjective cognitive impairment (SCI)1 intervention
Group C: Mild cognitive impairment (MCI)1 intervention
Group D: Alzheimer's disease (AD)1 intervention
Group E: Vascular cognitive impairment (VCI)1 intervention

Trial outcomes

Primary outcomes

1

Prevalence, incidence of cognitive impairment caused by neurological disease such as AD, VCI and other types of dementia

All of the participants will be evaluated by cognitive assessment scale annually.

Time frame
5 years
2

The conversion rate of normal aging to SCI, MCI and AD

All of the participants will be evaluated by cognitive assessment scale annually.

Time frame
5 years
3

The fluid biomarkers for normal aging, SCI, MCI and AD diagnosis

Cerebrospinal fluid, plasma, saliva and urine biomarkers included Aβ42, Aβ40, phosphated tau and total tau, and other novel biomarkers.

Time frame
5 years
4

The imaging biomarkers for normal aging, MCI and AD diagnosis

Imaging biomarkers included cerebral atrophy, amyloid and tau deposition of whole brain or hippocampus, glucose metabolism and other novel biomarkers.

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

The Central Hospital of Lishui City

Collaborator

Zhejiang Rehabilitation Center

Collaborator

Source ClinicalTrials.gov
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