Delayed Neurocognitive RecoveryNCT05105451
Study on the Characteristics of Non-targeted Metabolomics and EEG of Delayed Neurocognitive Recovery in Elderly Patients
An observational study of Delayed Neurocognitive Recovery, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
Perioperative neurocognitive disorder (PND) refers to a broad range of postoperative cognitive complications, including preoperatively diagnosed cognitive decline, postoperative delirium (POD), delayed neurocognitive recovery (dNCR), and neurocognitive disorders . Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delayed Neurocognitive Recovery
- What is being tested?
- Collecting clinical data, EGG，arterial blood gas data and venous blood sample
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2021to 30 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Our research is a single center, nested case-control study. Preoperatively collect the information of the elderly patients over 65 years old without undergoing craniocerebral operations, including the vital signs, the examination reports and other related data after excluding the factors that can't be included in the group. The patients' health scales and dNCR. scales were evaluated.
Who may be able to join
- Gender: no gender limit
- 65 years or older .
- Complete the operation in our hospital
- ASA classification I-II level
- Agree to participate in this research and agree to sign an informed consent form
Who cannot join
- History of preoperative psychosis and psychotropic drug use
- The subject is diagnosed with AD;
- Abnormal preoperative mental scale assessment
- Have a history of emergency rescue during the perioperative period
Trial locations and contacts
1 site in 1 country.
About this study
Perioperative neurocognitive disorder (PND) refers to a broad range of postoperative cognitive complications, including preoperatively diagnosed cognitive decline, postoperative delirium (POD), delayed neurocognitive recovery (dNCR), and neurocognitive disorders . Among them, dNCR refers to a decline in cognitive function that occurs approximately 1-4 weeks after anesthesia/surgery in elderly patients. It is associated with an increased risk of postoperative complications and an increased length of hospital stay.
The identification of potential predictive biomarkers would be beneficial for determining the individual risk of developing dNCR and for postoperative management of elderly patients. Although some predictive markers for PNDs, such as inflammatory factors, tau protein, S100B protein, neuron-specific enolase, and brain-derived neurotrophic factor, are widely known, most of them are postoperative predictive markers. The markers that can be used to predict PNDs before anesthesia/surgery are still largely unknown.
Preoperative markers allow us to identify individuals who are susceptible to dNCR and intervene early. It is unclear whether the metabolic status of preoperative patients is related to the occurrence of postoperative cognitive dysfunction (POCD). In the framework of systems biology based on genome, transcriptome, proteome, and metabolome, metabolomics is the closest to biological phenotypes because it reflects biological events that have occurred in living organisms. Considering that metabolome reflects the metabolites of all biochemical reactions that have already taken place in an organism and contains a huge amount of information about an organism's health, preoperative patient metabolites may be a useful predictive biomarker. In this study, we used serum metabolomics to develop non-invasive, easily detectable, and inexpensive preoperative biomarkers from patient blood to determine the individual risk of dNCR and the relationship between metabolic system abnormalities and the pathogenesis of dNCR.
- Conditions
- Delayed Neurocognitive Recovery
- Being tested
- Collecting clinical data, EGG，arterial blood gas data and venous blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting clinical data, EGG，arterial blood gas data and venous blood sampleOther
Collecting clinical data(before induction of anesthesia and first day after surgery), EGG（first day after surgery），arterial blood gas data(before induction of anesthesia and first day after surgery) and venous blood sample （before induction of anesthesia and first day, third day and 7th day after surgery）
| Study group | Role | What they receive |
|---|---|---|
| Patients in the control group were followed up without dNCR postoperatively. | If the MOCA or MMSE assessment all show a negative resluts at all time point. Receives: Other: Collecting clinical data, EGG，arterial blood gas data and venous blood sample | |
| Patients in the case group were followed up with dNCR postoperatively. | If the MOCA assessment is positive at any time point after surgery, and there is a positive MMSE at any time point after surgery(no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR. Receives: Other: Collecting clinical data, EGG，arterial blood gas data and venous blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSE (mini-mental state examiniation)
MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.
Measured: 1 day after surgery
MOCA (Montreal Cognitive Assessment)
MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.
Measured: 1 day after surgery
MMSE (mini-mental state examiniation)
MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.
Measured: 3 day after surgery
MOCA (Montreal Cognitive Assessment)
MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.
Measured: 3 day after surgery
MMSE (mini-mental state examiniation)
MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR. a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.
Measured: 7 day after surgery
MOCA (Montreal Cognitive Assessment)
MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.
Measured: 7 day after surgery
MOCA (Montreal Cognitive Assessment)
MOCA sacle score,baseline
Measured: right before surgery
MMSE (mini-mental state examiniation)
MMSE scale score, baseline
Measured: right before surgery
T-MoCA (The telephone MoCA)
MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.
Measured: 15 day after surgery
T-MoCA (The telephone MoCA)
MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.
Measured: 30 day after surgery
Secondary outcomes (3)
3D-CAM
3D-CAM score
Measured: 1 day after surgery
Self-Rating Anxiety Scale
Self-Rating Anxiety Scale score
Measured: right before surgery
Self-rating depression scale
Self-rating depression scale score
Measured: right before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start22 May 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
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 Delayed Neurocognitive RecoveryStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe 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
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Jiang, Doctor, Study director, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105451
- Sponsor's protocol ID
- SH9H-2021-T120
- Status last verified
- Jul 2023
- First submitted
- 28 May 2021
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang L, Liu J, Zhou R, Liu J, Zhang J, Mao H, Yan J, Jiang H. Preoperative tyrosine is associated with postoperative delayed neurocognitive recovery in elderly: Evidence from two hospitals. Clin Nutr ESPEN. 2025 Aug;68:727-736. doi: 10.1016/j.clnesp.2025.06.016. Epub 2025 Jun 13.
PubMed 40518008Mao H, Huang H, Zhou R, Zhu J, Yan J, Jiang H, Zhang L. High preoperative blood oxaloacetate and 2-aminoadipic acid levels are associated with postoperative delayed neurocognitive recovery. Front Endocrinol (Lausanne). 2023 Jul 31;14:1212815. doi: 10.3389/fendo.2023.1212815. eCollection 2023.
PubMed 37583434
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Characteristics of Non-targeted Metabolomics and EEG of Delayed Neurocognitive Recovery in Elderly Patients
- ClinicalTrials.gov ID
- NCT05105451
- Acronym / sponsor ID
- SH9H-2021-T120
- Conditions
- Delayed Neurocognitive Recovery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 22 May 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Nov 2021 (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.
Perioperative neurocognitive disorder (PND) refers to a broad range of postoperative cognitive complications, including preoperatively diagnosed cognitive decline, postoperative delirium (POD), delayed neurocognitive recovery (dNCR), and neurocognitive disorders . Among them, dNCR refers to a decline in cognitive function that occurs approximately 1-4 weeks after anesthesia/surgery in elderly patients. It is associated with an increased risk of postoperative complications and an increased length of hospital stay.
The identification of potential predictive biomarkers would be beneficial for determining the individual risk of developing dNCR and for postoperative management of elderly patients. Although some predictive markers for PNDs, such as inflammatory factors, tau protein, S100B protein, neuron-specific enolase, and brain-derived neurotrophic factor, are widely known, most of them are postoperative predictive markers. The markers that can be used to predict PNDs before anesthesia/surgery are still largely unknown.
Preoperative markers allow us to identify individuals who are susceptible to dNCR and intervene early. It is unclear whether the metabolic status of preoperative patients is related to the occurrence of postoperative cognitive dysfunction (POCD). In the framework of systems biology based on genome, transcriptome, proteome, and metabolome, metabolomics is the closest to biological phenotypes because it reflects biological events that have occurred in living organisms. Considering that metabolome reflects the metabolites of all biochemical reactions that have already taken place in an organism and contains a huge amount of information about an organism's health, preoperative patient metabolites may be a useful predictive biomarker. In this study, we used serum metabolomics to develop non-invasive, easily detectable, and inexpensive preoperative biomarkers from patient blood to determine the individual risk of dNCR and the relationship between metabolic system abnormalities and the pathogenesis of dNCR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients in the control group were followed up without dNCR postoperatively. | – | Other: Collecting clinical data, EGG，arterial blood gas data and venous blood sampleIf the MOCA or MMSE assessment all show a negative resluts at all time point. |
| Patients in the case group were followed up with dNCR postoperatively. | – | Other: Collecting clinical data, EGG，arterial blood gas data and venous blood sampleIf the MOCA assessment is positive at any time point after surgery, and there is a positive MMSE at any time point after surgery(no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Our research is a single center, nested case-control study. Preoperatively collect the information of the elderly patients over 65 years old without undergoing craniocerebral operations, including the vital signs, the examination reports and other related data after excluding the factors that can't be included in the group. The patients' health scales and dNCR. scales were evaluated.
Key inclusion criteria (5 listed)
- Gender: no gender limit
- 65 years or older .
- Complete the operation in our hospital
- ASA classification I-II level
- Agree to participate in this research and agree to sign an informed consent form
Key exclusion criteria (4 listed)
- History of preoperative psychosis and psychotropic drug use
- The subject is diagnosed with AD;
- Abnormal preoperative mental scale assessment
- Have a history of emergency rescue during the perioperative period
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 |
|---|---|---|
| Collecting clinical data, EGG，arterial blood gas data and venous blood sampleCollecting clinical data(before induction of anesthesia and first day after surgery), EGG（first day after surgery），arterial blood gas data(before induction of anesthesia and first day after surgery) and venous blood sample （before induction of anesthesia and first day, third day and 7th day after surgery） | Other | Patients in the case group were followed up with dNCR postoperatively., Patients in the control group were followed up without dNCR postoperatively. |
Primary outcome
MMSE (mini-mental state examiniation)
Time frame: 1 day after surgery
MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.
MOCA (Montreal Cognitive Assessment)
Time frame: 1 day after surgery
MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.
MMSE (mini-mental state examiniation)
Time frame: 3 day after surgery
MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.
MOCA (Montreal Cognitive Assessment)
Time frame: 3 day after surgery
MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.
MMSE (mini-mental state examiniation)
Time frame: 7 day after surgery
MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR. a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.
MOCA (Montreal Cognitive Assessment)
Time frame: 7 day after surgery
MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.
MOCA (Montreal Cognitive Assessment)
Time frame: right before surgery
MOCA sacle score,baseline
MMSE (mini-mental state examiniation)
Time frame: right before surgery
MMSE scale score, baseline
T-MoCA (The telephone MoCA)
Time frame: 15 day after surgery
MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.
T-MoCA (The telephone MoCA)
Time frame: 30 day after surgery
MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.
3 secondary outcomes
3D-CAM
Time frame: 1 day after surgery
Self-Rating Anxiety Scale
Time frame: right before surgery
Self-rating depression scale
Time frame: right before surgery
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 18 Jul 2023.
- Derived from this study: PubMed 40518008Zhang L, Liu J, Zhou R, Liu J, Zhang J, Mao H, Yan J, Jiang H. Preoperative tyrosine is associated with postoperative delayed neurocognitive recovery in elderly: Evidence from two hospitals. Clin Nutr ESPEN. 2025 Aug;68:727-736. doi: 10.1016/j.clnesp.2025.06.016. Epub 2025 Jun 13.
- Derived from this study: PubMed 37583434Mao H, Huang H, Zhou R, Zhu J, Yan J, Jiang H, Zhang L. High preoperative blood oxaloacetate and 2-aminoadipic acid levels are associated with postoperative delayed neurocognitive recovery. Front Endocrinol (Lausanne). 2023 Jul 31;14:1212815. doi: 10.3389/fendo.2023.1212815. eCollection 2023.
- 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. This study is not recruiting at the moment.
Hong Jiang, Doctor study director
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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 Delayed Neurocognitive Recovery, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 18 Jul 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?
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?
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?
MMSE (mini-mental state examiniation) (time frame: 1 day after surgery). The study lists 10 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 NCT05105451, 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 18 Jul 2023.