Cognitive ImpairmentCODENCT03251573
The Cohort Study of Cognitive Impairment in Chinese Hemodialysis Patients
An observational study of Cognitive Impairment and Hemodialysis Complication, run by Beijing Shijitan Hospital, Capital Medical University at 1 site in China.
Trial summary
This study is going to apply neuropsychological battery tests to measure cognitive function across multiple cognitive domains in our cohort of 600 maintenance hemodialysis patients and evaluate: 1. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cognitive Impairment, Hemodialysis Complication, Outcome
- What is being tested?
- cognitive impairment
- How many people
- 613 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 18 Jun 2019
- How long will I take part?
- 2 Years
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese Maintenace Hemodialysis Patients
Who may be able to join
- Subjects have end-stage kidney disease and are treated with long-term outpatient haemodialysis in each investigational site for at least the previous 3 months;
- 50 ~ 80 years old;
- willing to provide written and informed consent.
Who cannot join
- Subjects have disturbance of consciousness or mental disorder;
- Subjects have sensory (visual and hearing) or motor impairment, which disabled them to complete the tests that required these senses;
- Subjects have a life expectancy less than 6 months according to their physician, have a planned kidney transplantation within 6 months of baseline, or have anticipated recovery of kidney function.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Shijitan Hospital affiliated to Capital Medical University
Beijing, 100038
About this study
Official title: The Cohort Study of Cognitive Impairment and Its Association With Clinical Outcomes in Chinese Maintenance Hemodialysis Patients
This study is going to apply neuropsychological battery tests to measure cognitive function across multiple cognitive domains in our cohort of 600 maintenance hemodialysis patients and evaluate:
- The presence and patterns of cognitive impairment in domains of executive function, perceptual-motor function, language, learning and memory, and complex attention;
- Clinical characteristics of participants with and without cognitive impairment;
- the risk factors which might be related to cognitive impairment in this group of population;
- The association between cognitive impairment and all-cause mortality, stroke and non-fatal cardiovascular events;
We hypothesize that hemodialysis patient is going to have cognitive impairment which might be associated with some risk factors. We also anticipate that cognitive impairment might have some kind of association with the clinical outcomes like all-cause mortality, stroke and other common clinical outcomes that we mentioned above.
Read the detailed description
Neuropsychological assessment All neuropsychological assessments were performed by the research staff that was centrally trained and certified by the study neuropsychologist to conduct the assessments before study commencement. All research staff and patients were native Chinese speakers. Neuropsychological assessment was conducted individually in a separate room on the day after a dialysis session and required on average approximately 90 minutes. Global cognitive function was screened by the Chinese Beijing version of the Montreal Cognitive Assessment (MoCA-BJ).10 The comprehensive battery of neuropsychological tests was designed to assess five cognitive domains: (1) attention/processing speed, using Symbol Digit Modalities Test and the Chinese modified version of the Trail Making Test A,11,12(2) executive function, using the Chinese modified version of the Trail Making Tests B , and a modified version of the Stroop Color-Word Test;13 (3) verbal memory, using the Chinese version of the Auditory Verbal Learning Test for short-delay and long-delay free recall14 and Complex Figure for visual memory (delayed recall test; Chinese version);12 (4) language, using the Chinese modified versions of Boston Naming Test (the 30-item version) and Animal Fluency Test;15,16and (5) visuospatial function, using the Rey-Osterrieth Complex Figure (copy test).17,18 Depression was assessed using the Hamilton Depression Scale, with scores ranging from 0 to 63 and a score of 7 or above suggested as the optimal cutoff for suspected depression.
- Being tested
- cognitive impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive impairmentOther
one are of patients were exposed to cognitive impairment
| Study group | Role | What they receive |
|---|---|---|
| Normal cognitive function | The cognitive impairment classification algorithm We classified subjects as having no, mild, or major cognitive impairment using criteria from the fifth version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) as a guideline.20 The age and/or education-adjusted raw score of each individual cognitive test was calculated and compared with the age and/or education-adjusted published norms for Chinese populations.14 Specifically, age- and education-adjusted scores less than 1.5 standard deviations (SDs) below the adjusted mean of the published population norms on all tests in all domains indicated no cognitive impairment; scores of 1.50 to 1.99 SDs and 2.0 or more SDs below the adjusted mean of the published norms on at least one test in at least one domain indicated mild cognitive impairment and major cognitive impairment, respectively | |
| cognitive impairment | The cognitive impairment classification algorithm We classified subjects as having no, mild, or major cognitive impairment using criteria from the fifth version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) as a guideline.20 The age and/or education-adjusted raw score of each individual cognitive test was calculated and compared with the age and/or education-adjusted published norms for Chinese populations.14 Specifically, age- and education-adjusted scores less than 1.5 standard deviations (SDs) below the adjusted mean of the published population norms on all tests in all domains indicated no cognitive impairment; scores of 1.50 to 1.99 SDs and 2.0 or more SDs below the adjusted mean of the published norms on at least one test in at least one domain indicated mild cognitive impairment and major cognitive impairment, respectively Receives: Other: cognitive impairment |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive function
This study is going to apply neuropsychological battery tests to measure cognitive function across multiple cognitive domains
Measured: This measurement is going to be completed within 3 months after the first participant enrolls.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start1 Sep 2017
- Primary completion18 Jun 2019
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies 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
- 613 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Beijing Shijitan Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Luo, Chief, MD, PhD, Beijing Shijitan Hospital, Capital Medical University
- Investigators
- Yang Luo, MD, PhD, Principal investigator, Beijing Shijitan Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251573
- Sponsor's protocol ID
- Z161100002616005
- Acronym
- CODE
- Status last verified
- Jul 2019
- First submitted
- 14 Aug 2017
- Last updated
- 12 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guo Y, Tian R, Ye P, Luo Y. Frailty in Older Patients Undergoing Hemodialysis and Its Association with All-Cause Mortality: A Prospective Cohort Study. Clin Interv Aging. 2022 Mar 15;17:265-275. doi: 10.2147/CIA.S357582. eCollection 2022.
PubMed 35313671Tian R, Bai Y, Guo Y, Ye P, Luo Y. Association Between Sleep Disorders and Cognitive Impairment in Middle Age and Older Adult Hemodialysis Patients: A Cross-Sectional Study. Front Aging Neurosci. 2021 Dec 8;13:757453. doi: 10.3389/fnagi.2021.757453. eCollection 2021.
PubMed 34955811
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cohort Study of Cognitive Impairment and Its Association With Clinical Outcomes in Chinese Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03251573
- Acronym / sponsor ID
- CODE / Z161100002616005
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 613 participants (actual)
- Lead sponsor
- Beijing Shijitan Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 18 Jun 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 16 Aug 2017 (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 study is going to apply neuropsychological battery tests to measure cognitive function across multiple cognitive domains in our cohort of 600 maintenance hemodialysis patients and evaluate:
- The presence and patterns of cognitive impairment in domains of executive function, perceptual-motor function, language, learning and memory, and complex attention;
- Clinical characteristics of participants with and without cognitive impairment;
- the risk factors which might be related to cognitive impairment in this group of population;
- The association between cognitive impairment and all-cause mortality, stroke and non-fatal cardiovascular events;
We hypothesize that hemodialysis patient is going to have cognitive impairment which might be associated with some risk factors. We also anticipate that cognitive impairment might have some kind of association with the clinical outcomes like all-cause mortality, stroke and other common clinical outcomes that we mentioned above.
Detailed description
Neuropsychological assessment All neuropsychological assessments were performed by the research staff that was centrally trained and certified by the study neuropsychologist to conduct the assessments before study commencement. All research staff and patients were native Chinese speakers. Neuropsychological assessment was conducted individually in a separate room on the day after a dialysis session and required on average approximately 90 minutes. Global cognitive function was screened by the Chinese Beijing version of the Montreal Cognitive Assessment (MoCA-BJ).10 The comprehensive battery of neuropsychological tests was designed to assess five cognitive domains: (1) attention/processing speed, using Symbol Digit Modalities Test and the Chinese modified version of the Trail Making Test A,11,12(2) executive function, using the Chinese modified version of the Trail Making Tests B , and a modified version of the Stroop Color-Word Test;13 (3) verbal memory, using the Chinese version of the Auditory Verbal Learning Test for short-delay and long-delay free recall14 and Complex Figure for visual memory (delayed recall test; Chinese version);12 (4) language, using the Chinese modified versions of Boston Naming Test (the 30-item version) and Animal Fluency Test;15,16and (5) visuospatial function, using the Rey-Osterrieth Complex Figure (copy test).17,18 Depression was assessed using the Hamilton Depression Scale, with scores ranging from 0 to 63 and a score of 7 or above suggested as the optimal cutoff for suspected depression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal cognitive function | – | –The cognitive impairment classification algorithm We classified subjects as having no, mild, or major cognitive impairment using criteria from the fifth version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) as a guideline.20 The age and/or education-adjusted raw score of each individual cognitive test was calculated and compared with the age and/or education-adjusted published norms for Chinese populations.14 Specifically, age- and education-adjusted scores less than 1.5 standard deviations (SDs) below the adjusted mean of the published population norms on all tests in all domains indicated no cognitive impairment; scores of 1.50 to 1.99 SDs and 2.0 or more SDs below the adjusted mean of the published norms on at least one test in at least one domain indicated mild cognitive impairment and major cognitive impairment, respectively |
| cognitive impairment | – | Other: cognitive impairmentThe cognitive impairment classification algorithm We classified subjects as having no, mild, or major cognitive impairment using criteria from the fifth version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) as a guideline.20 The age and/or education-adjusted raw score of each individual cognitive test was calculated and compared with the age and/or education-adjusted published norms for Chinese populations.14 Specifically, age- and education-adjusted scores less than 1.5 standard deviations (SDs) below the adjusted mean of the published population norms on all tests in all domains indicated no cognitive impairment; scores of 1.50 to 1.99 SDs and 2.0 or more SDs below the adjusted mean of the published norms on at least one test in at least one domain indicated mild cognitive impairment and major cognitive impairment, respectively |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese Maintenace Hemodialysis Patients
Key inclusion criteria (3 listed)
- Subjects have end-stage kidney disease and are treated with long-term outpatient haemodialysis in each investigational site for at least the previous 3 months;
- 50 ~ 80 years old;
- willing to provide written and informed consent.
Key exclusion criteria (3 listed)
- Subjects have disturbance of consciousness or mental disorder;
- Subjects have sensory (visual and hearing) or motor impairment, which disabled them to complete the tests that required these senses;
- Subjects have a life expectancy less than 6 months according to their physician, have a planned kidney transplantation within 6 months of baseline, or have anticipated recovery of kidney function.
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 |
|---|---|---|
| cognitive impairmentone are of patients were exposed to cognitive impairment | Other | cognitive impairment |
Primary outcome
cognitive function
Time frame: This measurement is going to be completed within 3 months after the first participant enrolls.
This study is going to apply neuropsychological battery tests to measure cognitive function across multiple cognitive domains
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Derived from this study: PubMed 35313671Guo Y, Tian R, Ye P, Luo Y. Frailty in Older Patients Undergoing Hemodialysis and Its Association with All-Cause Mortality: A Prospective Cohort Study. Clin Interv Aging. 2022 Mar 15;17:265-275. doi: 10.2147/CIA.S357582. eCollection 2022.
- Derived from this study: PubMed 34955811Tian R, Bai Y, Guo Y, Ye P, Luo Y. Association Between Sleep Disorders and Cognitive Impairment in Middle Age and Older Adult Hemodialysis Patients: A Cross-Sectional Study. Front Aging Neurosci. 2021 Dec 8;13:757453. doi: 10.3389/fnagi.2021.757453. eCollection 2021.
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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.
Yang Luo, MD, PhD principal investigator
Beijing Shijitan Hospital, Capital Medical University
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 and Hemodialysis Complication, run by Beijing Shijitan Hospital, Capital Medical University 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?
The sponsor lists 3 inclusion and 3 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: finished, as of the sponsor's last update on 12 Jul 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive function (time frame: This measurement is going to be completed within 3 months after the first participant enrolls.). 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 NCT03251573, which also lists 2 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 12 Jul 2019.