AgingCLACISNCT05468905
China Longitudinal Aging and Cognitive Impairment Study
An observational study of Aging and Mild Cognitive Impairment, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- None of intervention
- How many people
- 4,000 participants
- Where
- 2 sitesChina
- Study dates
- 10 Jan 2021to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male or female participants ages 40 to 99 years
Who may be able to join
- 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.
- 5. Insidious onset, slow progress.
- Alzheimer's disease (AD)
- 50 years and older
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- 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)
- 1. 40 years and older 2. Diagnosis according to the criteria for small vessel VCI, with the following three core elements:
- 1) 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.
- 4. 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.
- 5. Subjects and their informed persons can complete relevant and follow-up examinations.
- 6. Subjects or their authorized legal guardians sign the informed consent.
Who cannot join
- 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.)
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- 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
- hearing impairment, visual impairment and poor coordination
- withdraw or reject the study Subjective cognitive impairment (SCI) and Mild cognitive impairment (MCI)
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- With history of stroke and a neurological focal sign, the imaging findings are consistent with cerebral vascular disease (Fazekas score ≥ 2 points).
- Other neurological diseases that can cause brain dysfunction (such as depression, brain tumor, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal intracranial pressure hydrocephalus, etc.).
- Other systemic diseases that can cause cognitive impairment（such as liver, renal and thyroid insufficiency, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.）.
- Mental and neurodevelopmental retardation.
- Other diseases known to cause cognitive impairment.
- Contraindications to nuclear magnetics.
- Suffering from a disease that cannot be combined with cognitive examination.
- Refuse to draw blood.
- Refuse to sign the informed consent at baseline Alzheimer's disease (AD)
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- Other neurological diseases that can cause brain dysfunction (such as depression, brain tumor, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal intracranial pressure hydrocephalus, etc.).
- Other systemic diseases that can cause cognitive impairment（such as liver, renal and thyroid insufficiency, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.）.
- Mental and neurodevelopmental retardation.
- Other diseases known to cause cognitive impairment.
- Contraindications to nuclear magnetics.
- Suffering from a disease that cannot be combined with cognitive examination.
- Refuse to draw blood.
- Refuse to sign the informed consent at baseline Vascular cognitive impairment (VCI)
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- Other neurological diseases that can cause brain dysfunction (such as depression, brain tumor, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal intracranial pressure hydrocephalus, etc.).
- Other systemic diseases that can cause cognitive impairment（such as liver, renal, and thyroid insufficiency, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.）.
- Other diseases known to cause cognitive impairment.
- Hereditary or inflammatory small vessel disease, such as cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL).
- Contraindications to nuclear magnetics.
- Refuse to draw blood.
- Refuse to sign the informed consent at baseline
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Qing-Qing Tao, M.D.&Ph.D, 13777820430, qingqingtao@zju.edu.cn
Zhi-Ying Wu, M.D.&Ph.D
- Recruiting
Zhejiang Lishui central Hospital
Lishui, Zhejiang, 323000
Hui-Fen Huang, M.D., 13666564106, wuyumomo@aliyun.com
About this study
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.
Read the 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.
- Conditions
- Aging, Mild Cognitive Impairment, Alzheimer Disease, Neurodegeneration
- Being tested
- None of intervention
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None of interventionOther
None of intervention
| Study group | Role | What they receive |
|---|---|---|
| Cognitive normal Aging (CN) | Normal aging subjects with normal cognitive function Receives: 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?" Receives: Other: None of intervention | |
| Mild cognitive impairment (MCI) | Mild cognitive impairment subjects with memory loss as predominant symptom Receives: Other: None of intervention | |
| Alzheimer's disease (AD) | Mild to moderate sporadic and familial Alzheimer disease subjects Receives: Other: None of intervention | |
| Vascular cognitive impairment (VCI) | Cognitive impairment subjects caused by cerebral vessel disease Receives: Other: None of intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 years
Gut microbiota
Fecal microbiome will be analyzed by 16S rRNA gene sequencing and metagenome sequencing.
Measured: 5 years
Gait
Gait characteristics such as stride-to-stride variability of stride time, and gait speed were evaluated by 3D gait detection.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start10 Jan 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Central Hospital of Lishui City, Zhejiang Rehabilitation Center
- Responsible party
- Sponsor
- Investigators
- Zhi-Ying Wu, M.D&Ph.D, Study chair, Second Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468905
- Sponsor's protocol ID
- wulab-CLACIS
- Acronym
- CLACIS
- Status last verified
- Jul 2022
- First submitted
- 18 Jul 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Longitudinal Aging and Cognitive Impairment Study
- ClinicalTrials.gov ID
- NCT05468905
- Acronym / sponsor ID
- CLACIS / wulab-CLACIS
- Conditions
- Aging, Mild Cognitive Impairment, Alzheimer Disease, Neurodegeneration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The Central Hospital of Lishui City, Zhejiang Rehabilitation Center
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cognitive normal Aging (CN) | – | Other: None of interventionNormal aging subjects with normal cognitive function |
| Subjective cognitive impairment (SCI) | – | Other: None of interventionSelf-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) | – | Other: None of interventionMild cognitive impairment subjects with memory loss as predominant symptom |
| Alzheimer's disease (AD) | – | Other: None of interventionMild to moderate sporadic and familial Alzheimer disease subjects |
| Vascular cognitive impairment (VCI) | – | Other: None of interventionCognitive impairment subjects caused by cerebral vessel disease |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female participants ages 40 to 99 years
Key inclusion criteria (17 listed)
- 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.
- 5. Insidious onset, slow progress.
- Alzheimer's disease (AD)
Key exclusion criteria (44 listed)
- Cognitive normal aging (CN)
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Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None of interventionNone of intervention | Other | Alzheimer's disease (AD), Cognitive normal Aging (CN), Mild cognitive impairment (MCI), Subjective cognitive impairment (SCI), Vascular cognitive impairment (VCI) |
Primary outcome
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.
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.
Gut microbiota
Time frame: 5 years
Fecal microbiome will be analyzed by 16S rRNA gene sequencing and metagenome sequencing.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhi-Ying Wu, M.D&Ph.D study chair
Second Affiliated Hospital of Zhejiang University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Mild Cognitive Impairment, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qing-Qing Tao, M.D. (13777820430, qingqingtao@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence, incidence of cognitive impairment caused by neurological disease such as AD, VCI and other types of dementia (time frame: 5 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.