China Longitudinal Aging and Cognitive Impairment Study

NCT05468905 | Recruiting

• 1 other identifier: wulab-CLACIS
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Aging; Mild Cognitive Impairment; Alzheimer Disease; Neurodegeneration

Outcome Measures

Primary Outcomes (6)

• 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.

  5 years

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

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

  5 years

• 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.

  5 years

• 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.

  5 years

• Gut microbiota

  Fecal microbiome will be analyzed by 16S rRNA gene sequencing and metagenome sequencing.

  5 years

• Gait

  Gait characteristics such as stride-to-stride variability of stride time, and gait speed were evaluated by 3D gait detection.

  5 years

Study Arms (5)

Cognitive normal Aging (CN)

Normal aging subjects with normal cognitive function

Other: None of intervention

Subjective cognitive impairment (SCI)

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?"

Other: None of intervention

Mild cognitive impairment (MCI)

Mild cognitive impairment subjects with memory loss as predominant symptom

Other: None of intervention

Alzheimer's disease (AD)

Mild to moderate sporadic and familial Alzheimer disease subjects

Other: None of intervention

Vascular cognitive impairment (VCI)

Cognitive impairment subjects caused by cerebral vessel disease

Other: None of intervention

Interventions

None of intervention OTHER

None of intervention

Alzheimer's disease (AD); Cognitive normal Aging (CN); Mild cognitive impairment (MCI); Subjective cognitive impairment (SCI); Vascular cognitive impairment (VCI)

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male or female participants ages 40 to 99 years

You may qualify if:

• 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.
• \. Insidious onset, slow progress.
• Alzheimer's disease (AD)
• years and older
• Dementia is diagnosed according to the criteria described by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-R). The diagnosis of AD according to the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS- ADRDA) or National Institute on Aging and the Alzheimer's Assocation (NIA-AA) criteria.
• Subjects and their informed persons can complete relevant and follow-up examinations.
• Subjects or their authorized legal guardians sign the informed consent. Vascular cognitive impairment (VCI)
• \. 40 years and older 2. Diagnosis according to the criteria for small vessel VCI, with the following three core elements:
• \) Cognitive impairment: memory decline can be highlighted 2) Vascular factors 3) Causal relationship between cognitive impairment and vascular factors 3.Cognitive impairment lasts for 3 months or more, and the CDR global score ≥0.5 point.
• \. All patients need to meet the following MRI criteria:
• Multiple (≥3) small infarcts (3-20 mm in diameter) with or without any degree of white matter lesions (WML); or moderate to severe WML (Fazekas score ≥ 2) , with or without small infarction; or ≥ 1 small infarct in key parts of the cortex, such as: caudate nucleus, globus pallidus, thalamus et al.
• No WML caused by cortical infarction, watershed infarction, hemorrhage, hydrocephalus, or other causes (such as multiple sclerosis).
• No hippocampus or entorhinal cortex atrophy, Medial Temporal Lobe Atrophy (MTA)≤ 1 point.

You may not qualify if:

• 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.)
• metabolic and endocrine disorders (requiring new treatment or adjustment of current treatment for thyroid dysfunction, folate or vitamin B12 deficiency)
• unstable psychosis or long-term use of antipsychotic drugs (more than 6 months)
• history of malignant tumors (tumors of nervous system and other sites) active for nearly 1 year
• contraindications for MRI (e.g. pacemakers, stents, claustrophobia, etc.) or do not cooperate or cannot carry out PET examination
• uneducated illiterates

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• The Central Hospital of Lishui City: collaborator
• Zhejiang Rehabilitation Center: collaborator

Study Sites (2)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Zhejiang Lishui central Hospital

Lishui, Zhejiang, 323000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum retention in -80℃ fridge for ApoE4 gene test etc

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Nerve Degeneration

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhi-Ying Wu, M.D&Ph.D

  Second Affiliated Hospital of Zhejiang University School of Medicine

  STUDY CHAIR

Central Study Contacts

Qing-Qing Tao, M.D.

CONTACT

13777820430; qingqingtao@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 21, 2022
• Study Start: January 10, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)