Cognitive ImpairmentCANDORNCT04320368
China Alzheimer's and Neurodegenerative Disorder Research
An observational study of Cognitive Impairment, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This is a multi-center study that has three cohorts: 1) cognitive normal cohort (CN), 2) Alzheimer's disease cohort (AD) and 3) vascular cognitive impairment cohort (VCI). The goal of this study is to understand the risk factors of AD and VCI and to identify high risk patients for early intervention. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Cognitive Impairment
- How many people
- 3,100 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2019to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Alzheimer's disease cohort and post-stroke cognitive observation cohort will be recruited from participating hospitals. Cognitively normal cohort will be recruited from the community.
- The inclusion and exclusion criteria of AD group. 1.1 The AD group inclusion criteria: 1.1.1 Aged 40-100 years old (≥ 40 years old, ≤ 100 years old). 1.1.2 Diagnosed with AD according to Alzheimer disease diagnostic criteria following NINCDS-ADRDA1984 or NIA-AA 2011 guideline. 1.1.3 Had adequate hearing, vision and comprehension and verbal expression to complete the cognitive assessments. 1.1.4 Had at least 3 years of education. 1.1.5 Signed informed consent. 1.2 The AD group exclusion criteria: 1.2.1 Sequelae after previous history of severe central nervous system infection, multiple sclerosis, autoimmune encephalitis, Hashimoto's encephalopathy, etc. 1.2.2 Previous history of instable epilepsy. 1.2.3 Systemic diseases affect the central nervous system (CNS), such as abnormal liver and kidney functions. 1.2.4 History of hereditary diseases that affect cognitive function (such as Huntington's disease, Down's syndrome, CADASIL, adrenal leukodystrophy, mitochondrial encephalopathy, etc.). 1.2.5 Infection and immune-related diseases affecting the central nervous system (systemic lupus erythematosus, undertreated HIV infection or a history of CNS syphilis infection, etc.). 1.2.6 Metabolic and endocrine disorders (requiring new treatment or adjustment of current treatment for thyroid dysfunction, folate or vitamin B12 deficiency). 1.2.7 Had contraindications for MRI (e.g., pacemakers, stents, claustrophobia.) or did not cooperate with PET scans.
- The inclusion and exclusion criteria of post-stroke cognitive observation group. 2.1 The inclusion criteria of post-stroke cognitive observation group: 2.1.1 Aged 40-100-years old (≥ 40 years old, ≤ 100 years old). 2.1.2 Cerebral infarction is diagnosed according to World Health Organization diagnostic criteria13 and was the first symptomatic onset. 2.1.3 The time from onset to enrollment was less than 7 days. 2.1.4 Had adequate hearing, vision and comprehension and verbal expression to complete the cognitive assessments. 2.1.5 Had at least 3 years of education. 2.1.6 Signed informed consent. 2.2 The exclusion criteria of post-stroke cognitive observation group: 2.2.1 Prior to the onset of acute infarction had no conditions known to affect cognitive function, such as vascular dementia, dementia with Lewy body dementia, frontotemporal dementia, Parkinson's disease dementia, epilepsy, stroke, hydrocephalus, multiple sclerosis, traumatic brain injuries, genetic disorders affecting cognition, alcoholism, uncontrolled depression or other psychiatric disorders and Alzheimer's disease and IQCODE>3.5. 2.2.2 Sequelae after previous history of severe central nervous system infection, multiple sclerosis, autoimmune encephalitis, Hashimoto's encephalopathy, etc. 2.2.3 Previous history of instable epilepsy. 2.2.4 Systemic diseases affect the CNS, for abnormal liver and kidney functions. 2.2.5 History of hereditary diseases that affect cognitive function (such as Huntington's disease, down syndrome, CADASIL, adrenal leukodystrophy, mitochondrial encephalopathy, etc.). 2.2.6 Infection and immune-related diseases affecting the central nervous system (systemic lupus erythematosus, undertreated HIV infection or a history of CNS syphilis infection, etc.). 2.2.7 Metabolic and endocrine disorders (requiring new treatment or adjustment of current treatment for thyroid dysfunction, folate or vitamin B12 deficiency). 2.2.8 Reject or had contraindications for MRI (e.g., pacemakers, stents, claustrophobia.).
- The inclusion and exclusion criteria of normal cognitive group.
3.1 The inclusion criteria of normal cognitive group: 3.1.1 Aged 40-100 years old (≥ 40 years old, ≤ 100 years old). 3.1.2 The patients are cognitively normal and able to live and work independently.
3.1.3 Had adequate hearing, vision and comprehension and verbal expression to complete the cognitive assessments.
3.1.4 Had at least 3 years of education. 3.1.5 Signed informed consent.
3.2 The exclusion criteria of normal cognitive group: 3.2.1 The patients had no conditions known to affect cognitive function, such as vascular dementia, dementia with Lewy body dementia, frontotemporal dementia, Parkinson's disease, epilepsy, stroke, hydrocephalus, multiple sclerosis, traumatic brain injuries, genetic disorders affecting cognition, alcoholism, uncontrolled depression or other psychiatric disorders, Parkinson's disease, epilepsy or Alzheimer's disease.
3.2.2 Sequelae after previous history of severe central nervous system infection, multiple sclerosis, autoimmune encephalitis, Hashimoto's encephalopathy, etc.
3.2.3 Previous history of instable epilepsy. 3.2.4 Systemic diseases affect the CNS, for abnormal liver and kidney functions.
3.2.5 History of hereditary diseases that affect cognitive function (such as Huntington's disease, down syndrome, CADASIL, adrenal leukodystrophy, mitochondrial encephalopathy, etc.).
3.2.6 Infection and immune-related diseases affecting the central nervous system (systemic lupus erythematosus, undertreated HIV infection or a history of CNS syphilis infection, etc.).
3.2.7 Metabolic and endocrine disorders (requiring new treatment or adjustment of current treatment for thyroid dysfunction, folate or vitamin B12 deficiency).
3.2.8 Reject or had contraindications for MRI (e.g., pacemakers, stents, claustrophobia.).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, 110000
Shiping Li, doctor, +86 15830116199, drlishiping@163.com
About this study
Official title: China National Clinical Research Center Alzheimer's Disease and Neurodegenerative Disorder Research
This is a multi-center study that has three cohorts: 1) cognitive normal cohort (CN), 2) Alzheimer's disease cohort (AD) and 3) vascular cognitive impairment cohort (VCI). The goal of this study is to understand the risk factors of AD and VCI and to identify high risk patients for early intervention. It will collect demographic information, family history, medical history, neuropsychological tests, imaging studies and biological samples through standard and uniform procedures.
Read the detailed description
In this prospective study, we will recruit subjects into one of the three groups based on inclusion and exclusion criteria: 1) CN, 2) AD and 3) VCI. We will follow up with each of them subject at designated time points up to 2 years. We will collect demographic, medical, imaging (MRI and PET scans), genetic information and various biological samples (blood, saliva, urine and feces) during the study period. This study uses a case-control study design. The matched cases will have similar age, gender and education levels. By studying the relationship between risk factors of AD and VCI, we will establish norms and parameters in the Chinese population.
- Conditions
- Cognitive Impairment
- Keywords
- Alzheimer's disease, vascular cognitive impairment, dementia
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's disease cohort | 1. Aged 40-100 years old (≥ 40 years old, ≤ 100 years old). 2. Diagnosed with AD according to Alzheimer disease diagnostic criteria following NINCDS-ADRDA 1984 or NIA-AA 2011 guideline. 3. Had adequate hearing, vision and comprehension and verbal expression to complete the cognitive assessments. 4. Had at least 3 years of education. 5. Signed informed consent. | |
| Post-stroke cognitive observation cohort | 1. Aged 40-100-years old (≥ 40 years old, ≤ 100 years old). 2. Cerebral infarction is diagnosed according to World Health Organization diagnostic criteria and was the first symptomatic onset. 3. The time from onset to enrollment was less than 7 days. 4. Had adequate hearing, vision and comprehension and verbal expression to complete the cognitive assessments. 5. Had at least 3 years of education. 6. Signed informed consent. | |
| A cohort of people with normal cognitive function | 1. Aged 40-100 years old (≥ 40 years old, ≤ 100 years old). 2. The patients are cognitively normal and able to live and work independently 3. Had adequate hearing, vision and comprehension and verbal expression to complete the cognitive assessments. 4. Had at least 3 years of education. 5. Signed informed consent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data records
We will record the number of participants at several follow-up visits, the basic condition at the follow-up. If the visit is not completed, record the cause of this loss.
At baseline, record the demographic information, past medical history and medication history, vital signs and neuropsychological scales. The PET-CT scan were recorded during the 4-year visit. Collect the results of cerebral MRI, laboratory tests and neuropsychological scales of all participants at baseline, 12, 24, 36 and 48 months and biological samples. For VCI cohort, we will record the basic conditions and partial neuropsychological scales at 3-month and 6-month follow-up.
Measured: 4-5 years
Neuropsychological scales
Mini-Mental State Examination (MMSE), Montreal-Cognitive Assessment (MoCA), the Geriatric Depression Scale (GDS), The Activities of Daily Living Questionnaire(ADL), Digit Span Memory Test, Rey Auditory Verbal Learning Test (RAVLT), Rey-Osterrieth Complex Figure Test(ROCF), Trail Making Test A and B, Stroop test, Verbal Fluency Test, Boston Naming Test, Clock-Drawing Test, Narcissism Test (NPI), Symbol Digit Modalities Test(SDMT), Clinical Dementia Rating (CDR)
Measured: 4-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start8 Jul 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- 3,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiping Li, Beijing Tiantan Hospital
- Investigators
- Shiping Li, MD, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320368
- Sponsor's protocol ID
- Z181100001518005
- Acronym
- CANDOR
- Status last verified
- Aug 2023
- First submitted
- 10 Mar 2020
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data are available upon reasonable request.
Publications
Prince MJ, Wu F, Guo Y, Gutierrez Robledo LM, O'Donnell M, Sullivan R, Yusuf S. The burden of disease in older people and implications for health policy and practice. Lancet. 2015 Feb 7;385(9967):549-62. doi: 10.1016/S0140-6736(14)61347-7. Epub 2014 Nov 6.
PubMed 25468153Alzheimer's Association. 2016 Alzheimer's disease facts and figures. Alzheimers Dement. 2016 Apr;12(4):459-509. doi: 10.1016/j.jalz.2016.03.001.
PubMed 27570871Wang Y, Wang Q, Tong L, Zheng H, Wang Y, Li S. U-shaped association between post-stroke cognitive impairment and high-density lipoprotein cholesterol at the acute period of stroke. Arch Gerontol Geriatr. 2025 Dec;139:106002. doi: 10.1016/j.archger.2025.106002. Epub 2025 Aug 26.
PubMed 40915091Li S, Dong H, Wang Y, Wang S, Lv X, Dong M, Tian S, Shi J. China Alzheimer's Disease and Neurodegenerative Disorder Research (CANDOR) -A Prospective Cohort Study for Alzheimer's Disease and Vascular Cognitive Impairment. J Prev Alzheimers Dis. 2024;11(1):214-221. doi: 10.14283/jpad.2023.97.
PubMed 38230734Wang Q, Wang Y, Li S, Shi J. PACAP-Sirtuin3 alleviates cognitive impairment through autophagy in Alzheimer's disease. Alzheimers Res Ther. 2023 Oct 27;15(1):184. doi: 10.1186/s13195-023-01334-2.
PubMed 37891608Wang Y, Wang S, Zhu W, Liang N, Zhang C, Pei Y, Wang Q, Li S, Shi J. Reading activities compensate for low education-related cognitive deficits. Alzheimers Res Ther. 2022 Oct 14;14(1):156. doi: 10.1186/s13195-022-01098-1.
PubMed 36242017
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China National Clinical Research Center Alzheimer's Disease and Neurodegenerative Disorder Research
- ClinicalTrials.gov ID
- NCT04320368
- Acronym / sponsor ID
- CANDOR / Z181100001518005
- Conditions
- Cognitive Impairment
- Keywords
- Alzheimer's disease, vascular cognitive impairment, dementia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,100 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Mar 2020 (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 study that has three cohorts: 1) cognitive normal cohort (CN), 2) Alzheimer's disease cohort (AD) and 3) vascular cognitive impairment cohort (VCI). The goal of this study is to understand the risk factors of AD and VCI and to identify high risk patients for early intervention. It will collect demographic information, family history, medical history, neuropsychological tests, imaging studies and biological samples through standard and uniform procedures.
Detailed description
In this prospective study, we will recruit subjects into one of the three groups based on inclusion and exclusion criteria: 1) CN, 2) AD and 3) VCI. We will follow up with each of them subject at designated time points up to 2 years. We will collect demographic, medical, imaging (MRI and PET scans), genetic information and various biological samples (blood, saliva, urine and feces) during the study period. This study uses a case-control study design. The matched cases will have similar age, gender and education levels. By studying the relationship between risk factors of AD and VCI, we will establish norms and parameters in the Chinese population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's disease cohort | – | –1. Aged 40-100 years old (≥ 40 years old, ≤ 100 years old). 2. Diagnosed with AD according to Alzheimer disease diagnostic criteria following NINCDS-ADRDA 1984 or NIA-AA 2011 guideline. 3. Had adequate hearing, vision and comprehension and verbal expression to complete the cognitive assessments. 4. Had at least 3 years of education. 5. Signed informed consent. |
| Post-stroke cognitive observation cohort | – | –1. Aged 40-100-years old (≥ 40 years old, ≤ 100 years old). 2. Cerebral infarction is diagnosed according to World Health Organization diagnostic criteria and was the first symptomatic onset. 3. The time from onset to enrollment was less than 7 days. 4. Had adequate hearing, vision and comprehension and verbal expression to complete the cognitive assessments. 5. Had at least 3 years of education. 6. Signed informed consent. |
| A cohort of people with normal cognitive function | – | –1. Aged 40-100 years old (≥ 40 years old, ≤ 100 years old). 2. The patients are cognitively normal and able to live and work independently 3. Had adequate hearing, vision and comprehension and verbal expression to complete the cognitive assessments. 4. Had at least 3 years of education. 5. Signed informed consent. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Alzheimer's disease cohort and post-stroke cognitive observation cohort will be recruited from participating hospitals. Cognitively normal cohort will be recruited from the community.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Data records
Time frame: 4-5 years
We will record the number of participants at several follow-up visits, the basic condition at the follow-up. If the visit is not completed, record the cause of this loss. At baseline, record the demographic information, past medical history and medication history, vital signs and neuropsychological scales. The PET-CT scan were recorded during the 4-year visit. Collect the results of cerebral MRI, laboratory tests and neuropsychological scales of all participants at baseline, 12, 24, 36 and 48 months and biological samples. For VCI cohort, we will record the basic conditions and partial neuropsychological scales at 3-month and 6-month follow-up.
Neuropsychological scales
Time frame: 4-5 years
Mini-Mental State Examination (MMSE), Montreal-Cognitive Assessment (MoCA), the Geriatric Depression Scale (GDS), The Activities of Daily Living Questionnaire(ADL), Digit Span Memory Test, Rey Auditory Verbal Learning Test (RAVLT), Rey-Osterrieth Complex Figure Test(ROCF), Trail Making Test A and B, Stroop test, Verbal Fluency Test, Boston Naming Test, Clock-Drawing Test, Narcissism Test (NPI), Symbol Digit Modalities Test(SDMT), Clinical Dementia Rating (CDR)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Background: PubMed 25468153Prince MJ, Wu F, Guo Y, Gutierrez Robledo LM, O'Donnell M, Sullivan R, Yusuf S. The burden of disease in older people and implications for health policy and practice. Lancet. 2015 Feb 7;385(9967):549-62. doi: 10.1016/S0140-6736(14)61347-7. Epub 2014 Nov 6.
- Background: PubMed 27570871Alzheimer's Association. 2016 Alzheimer's disease facts and figures. Alzheimers Dement. 2016 Apr;12(4):459-509. doi: 10.1016/j.jalz.2016.03.001.
- Derived from this study: PubMed 40915091Wang Y, Wang Q, Tong L, Zheng H, Wang Y, Li S. U-shaped association between post-stroke cognitive impairment and high-density lipoprotein cholesterol at the acute period of stroke. Arch Gerontol Geriatr. 2025 Dec;139:106002. doi: 10.1016/j.archger.2025.106002. Epub 2025 Aug 26.
- Derived from this study: PubMed 38230734Li S, Dong H, Wang Y, Wang S, Lv X, Dong M, Tian S, Shi J. China Alzheimer's Disease and Neurodegenerative Disorder Research (CANDOR) -A Prospective Cohort Study for Alzheimer's Disease and Vascular Cognitive Impairment. J Prev Alzheimers Dis. 2024;11(1):214-221. doi: 10.14283/jpad.2023.97.
- Derived from this study: PubMed 37891608Wang Q, Wang Y, Li S, Shi J. PACAP-Sirtuin3 alleviates cognitive impairment through autophagy in Alzheimer's disease. Alzheimers Res Ther. 2023 Oct 27;15(1):184. doi: 10.1186/s13195-023-01334-2.
- Derived from this study: PubMed 36242017Wang Y, Wang S, Zhu W, Liang N, Zhang C, Pei Y, Wang Q, Li S, Shi J. Reading activities compensate for low education-related cognitive deficits. Alzheimers Res Ther. 2022 Oct 14;14(1):156. doi: 10.1186/s13195-022-01098-1.
- Individual participant dataSharing planned: Yes. All data are available upon reasonable request.
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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. This study is not recruiting at the moment.
Shiping Li, MD study chair
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiping Li, Doctor (+86 15830116199, drlishiping@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data records (time frame: 4-5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04320368, which also lists 6 linked publications.
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 8 Aug 2023.