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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

  1. 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.
  2. 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.).
  3. 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.

Shiping Li, Doctor contact

+86 15830116199

drlishiping@163.com

China1 site, 1 recruiting
  • Beijing Tiantan Hospital,Capital Medical University

    Beijing, Beijing Municipality, 110000

    Shiping Li, doctor, +86 15830116199, drlishiping@163.com

    Recruiting

Other trials in China

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.

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 groups in NCT04320368
Study groupRoleWhat they receive
Alzheimer's disease cohort1. 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 cohort1. 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 function1. 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.

  1. 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

  2. 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.

  1. First posted25 Mar 2020
  2. Study start8 Jul 2019
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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)
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 25468153
  • Alzheimer'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 27570871
  • Wang 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 40915091
  • Li 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 38230734
  • Wang 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 37891608
  • Wang 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

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.

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