Cognitive DysfunctionNCT04369157
Zinc and Post-Operative Cognitive Dysfunction
An observational study of Cognitive Dysfunction, run by University of Reading at 2 sites in United Kingdom.
Trial summary
A decline in cognitive abilities following surgery (POCD: Post-Operative Cognitive Dysfunction) affects up to 47% of patients undergoing a surgical procedure. Risk factors include age, previous depression, alcohol and drug use, smoking, cognitive impairment as well as pre-operative biochemical and haematological… Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- Elective surgery
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Jan 2021to 23 Jun 2021
- 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 60 to 100 years
- All sexes
- Adult, Older adult
Study population: Adults aged over 60 years scheduled to undergo elective orthopaedic or colorectal surgery at the Royal Berkshire Hospital
Who may be able to join
- Aged 60 years or over
- Able to provide fully informed consent
- Scheduled to undergo orthopaedic (knee/hip replacement) or colorectal surgery
- English as their primary language
Who cannot join
- Under 60 years of age
- Unable to provide fully informed consent
- English not their primary language
- Not electing to undergo any surgery or surgery that is not a knee or hip replacement, or colorectal surgery
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
School of Psychology and Clinical Languages, University of Reading
Reading, Berkshire, RG6 6AL
Royal Berkshire Hospital
Reading, Berkshrie
About this study
Official title: The Role of Zinc and Inflammation in Susceptibility to Post-operative Cognitive Dysfunction
A decline in cognitive abilities following surgery (POCD: Post-Operative Cognitive Dysfunction) affects up to 47% of patients undergoing a surgical procedure. Risk factors include age, previous depression, alcohol and drug use, smoking, cognitive impairment as well as pre-operative biochemical and haematological abnormalities. Inflammation has been proposed as a potential cause, however, there is little empirical and clinical evidence in this area to determine aetiology or reduce risk of incidence.
Zinc is an important metal for brain function, with deficiency associated with poorer cognitive outcomes. In relation to POCD, biomarker studies have revealed that levels of a zinc-alpha-2-glycoprotein (AZGP1) were lower in patients with POCD. AZGP1 is a multifunctional glycoprotein implicated in cell adhesion, immune response, transmembrane transport and cellular proliferation. Microglia, the immune cells of the brain, are highly sensitive to changes in zinc which have been proposed to contribute to neurodegenerative disease as well as POCD. However, whilst animal studies looking at the effects of zinc on cognition have been promising, robust human trials are lacking.
Read more
This research aims to establish the role of zinc in POCD by determining associations between zinc status, inflammation, cognitive function, and biomarkers of POCD risk and incidence. This will be achieved by gathering clinical and cognitive data from a sample of older adults undergoing surgery. Blood samples will be taken pre and post-operatively to establish zinc status and plasma concentrations of biomarkers of POCD risk and incidence. Pre and post-operative cognitive assessments will also be conducted to measure memory and executive function. Incidence of POCD will be determined via neurological assessment according to diagnostic criteria.
Should associations between zinc status, POCD biomarkers, inflammation, cognitive performance and POCD incidence be established, not only would it lead to future work to investigate potential mechanisms of action as well as intervention studies looking to support zinc status, optimising early identification of individuals who may be at higher risk of developing POCD should lead to better patient outcomes.
Read the detailed description
Healthy older adults under-going elective surgery (knee replacement, hip replacement or colorectal surgery) will be recruited via the Royal Berkshire Hospital. Participants will be aged 60 years and above, will have the capacity to give fully informed consent and will be undergoing elective orthopaedic or colorectal surgery.
Participation will involve testing on 3 occasions: 48hours-3 weeks prior to surgery (in the participant's home), 1-3 days post-surgery (in the Royal Berkshire Hospital) and approximately one month post-surgery (in the participant's home).
On each occasion, the Montreal Cognitive Assessment (MoCA) and Confusion Assessment Method (CAM) will be administered along with various cognitive tests measuring executive function (Trials A \& B, Stroop, Letter memory task, verbal fluency) and memory (the episodic memory tests of free recall and recognition from the CERAD: Consortium to Establish a Registry for Alzheimer's Disease neuropsychological test battery), as well as completion of questionnaires to determine mood (the Hospital Anxiety and Depression Scale [HADS] and the Positive and Negative Affect Scale [PANAS]) and sleep quality (the Pittsburgh Sleep Quality Index). The cognitive testing should take approximately 30-40 minutes.
At the first session (pre-operation) only, dietary information will also be collected via a food frequency questionnaire, as well as measures of fluid and crystallised intelligence (the National Adult Reading Test and Block Design from the Wechsler Adult Intelligence Scale - Revised respectively).
In addition, at each visit, a blood sample (maximum volume of 9mL, less than one tablespoon) will be taken from the participants for analysis of zinc concentration and markers of POCD and inflammation.
- Conditions
- Cognitive Dysfunction
- Being tested
- Elective surgery
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective surgeryProcedure or surgery
Patients will be scheduled to undergo elective orthopaedic (knee/hip replacement) or colorectal surgery.
| Study group | Role | What they receive |
|---|---|---|
| Elective surgery group | Patients undergoing hip/knee replacements or colorectal surgery will be recruited and tested on 3 occasions: pre-op, post-op and at follow-up. POCD status will be determined at post-op and follow up. Cognitive function, zinc status, POCD biomarkers and inflammatory markers will be measured on all 3 occasions. Receives: Procedure: Elective surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline zinc status as a predictor of POCD incidence 1-3 days post-operation
Concentration of zinc in plasma/serum at baseline as a predictor for development of POCD 1-3 days post operation
Measured: 1-3 days post operation
Baseline zinc status as a predictor of POCD incidence at follow-up
Concentration of zinc in plasma/serum at baseline as a predictor for development of POCD at follow-up
Measured: One month post operation
POCD risk biomarker as a predictor of POCD incidence 1-3 days post operation
Concentration of POCD risk biomarker AZGP1 in plasma/serum at baseline as a predictor for development of POCD 1-3 days post operation
Measured: 1-3 days post operation
POCD risk biomarker as a predictor of POCD incidence at follow-up
Concentration of POCD risk biomarker AZGP1 in plasma/serum at baseline as a predictor for development of POCD at follow-up
Measured: One month post operation
Baseline cognitive function (global Z score) as a predictor of POCD incidence 1- 3 days post operation
Baseline cognitive function (global Z score) as a predictor for development of POCD 1-3 days post operation
Measured: 1-3 days post operation
Baseline cognitive function (global Z score) as a predictor of POCD incidence at follow-up
Baseline cognitive function (global Z score) as a predictor for development of POCD at follow-up
Measured: One month post operation
Secondary outcomes (22)
Baseline zinc status as a predictor of cognitive function (global Z score) 1-3 days
Concentration of zinc in plasma/serum at baseline as a predictor of cognitive function (global Z score) 1-3 days post operation
Measured: 1-3 days post operation
Baseline zinc status as a predictor of cognitive function (global Z score) at follow-up
Concentration of zinc in plasma/serum at baseline as a predictor of cognitive function at follow-up
Measured: One month post operation
Current zinc status and incidence of POCD 1-3 days post operation
Correlation between concentration of zinc in serum/plasma 1-3 days post
Measured: 1-3 days post operation
Current zinc status and incidence of POCD at follow-up
Correlation between concentration of zinc in serum/plasma at follow-up and POCD incidence at follow-up
Measured: One month post operation
Current zinc status and cognitive function (global Z score) 1-3 days post operation
Correlation between concentration of zinc in serum/plasma 1-3 days post operation and cognitive function (global Z score) 1-3 days post-operation
Measured: 1-3 days post operation
Current zinc status and cognitive function (global Z score) at follow-up
Correlation between concentration of zinc in serum/plasma at follow-up and cognitive function (global Z score) at follow-up
Measured: One month post operation
POCD risk biomarker AZGP1 at baseline as predictor of cognitive function (global Z score) 1-3 days post operation
Concentration of AZGP1 in plasma/serum at baseline as a predictor of cognitive function (global Z score) 1-3 days post operation
Measured: 1-3 days post operation
POCD risk biomarker AZGP1 at baseline as predictor of cognitive function (global Z score) at follow-up
Concentration of AZGP1 in plasma/serum at baseline as a predictor of cognitive function (global Z score) at follow-up
Measured: One month post operation
Correlation between POCD biomarkers (IL-6 and IL-2) 1-3 days post operation and POCD incidence 1-3 days post operation
Correlation between the concentration of POCD biomarkers (IL-6 and IL-2) in plasma/serum 1-3 days post-operation and development of POCD 1-3 days post operation
Measured: 1-3 days post operation
Correlation between POCD biomarkers (IL-6 and IL-2) at follow-up and POCD incidence at follow-up
Correlation between the concentration of POCD biomarkers (IL-6 and IL-2) in plasma/serum at follow-up and development of POCD at follow-up
Measured: One month post operation
Correlation between POCD biomarkers (IL-6 and IL-2) 1-3 days post operation and cognitive function (global Z score) 1-3 days post operation
Correlation between the concentration of POCD biomarkers (IL-6 and IL-2) in plasma/serum 1-3 days post-operation and cognitive function (global Z score) 1-3 days post operation
Measured: 1-3 days post operation
Correlation between POCD biomarkers (IL-6 and IL-2) at follow-up and cognitive function (global Z score) at follow-up
Correlation between the concentration of POCD biomarkers (IL-6 and IL-2) in plasma/serum at follow-up and cognitive function (global Z score) at follow-up
Measured: One month post operation
Mediating influence of POCD risk biomarker AZGP1 at baseline on a correlation between baseline zinc status and POCD incidence 1-3 days post operation
Baseline concentration of POCD risk biomarker AZGP1 in serum/plasma as a mediator of a correlation between concentration of zinc in plasma/serum at baseline and POCD incidence 1-3 days post operation
Measured: 1-3 days post operation
Mediating influence of POCD risk biomarker AZGP1 at baseline on a correlation between baseline zinc status and POCD incidence at follow-up
Baseline concentration of POCD risk biomarker AZGP1 in serum/plasma as a mediator of a correlation between concentration of zinc in plasma/serum at baseline and POCD incidence at follow-up
Measured: One month post operation
Mediating influence of POCD risk biomarker AZGP1 at baseline on a correlation between baseline zinc status and cognitive function (global Z score) 1-3 days post operation
Baseline concentration of POCD risk biomarker AZGP1 in serum/plasma as a mediator of a correlation between concentration of zinc in plasma/serum at baseline and cognitive function (global Z score) 1-3 days post operation
Measured: 1-3 days post operation
Mediating influence of POCD risk biomarker AZGP1 at baseline on a correlation between baseline zinc status and cognitive function (global Z score) at follow-up
Baseline concentration of POCD risk biomarker AZGP1 in serum/plasma as a mediator of a correlation between concentration of zinc in plasma/serum at baseline and cognitive function (global Z score) at follow-up
Measured: One month post operation
Mediating influence of POCD biomarkers (IL-6 and IL-2) on a correlation between zinc status and cognitive function (global Z score) 1-3 days post operation
Concentration of POCD biomarkers (IL-6 and IL-2) in serum/plasma 1-3 days post operation as a mediator of a correlation between concentration of zinc in plasma/serum and cognitive function (global Z score) 1-3 days post operation
Measured: 1-3 days post operation
Mediating influence of POCD biomarkers (IL-6 and IL-2) on a correlation between zinc status and cognitive function (global Z score) at follow-up
Concentration of POCD biomarkers (IL-6 and IL-2) in serum/plasma at follow-up as a mediator of a correlation between concentration of zinc in plasma/serum and cognitive function (global Z score) at follow-up
Measured: One month post operation
Mediating influence of baseline mood (PANAS) on a correlation between baseline cognitive function (global Z score) and POCD incidence 1-3 days post operation
Baseline mood (PANAS) as a mediator of a correlation between baseline cognitive function (global Z score) and POCD incidence 1-3 days post operation
Measured: 1-3 days post operation
Mediating influence of mood (PANAS) 1-3 days post operation on a correlation between baseline zinc status and cognitive function (global Z score) 1-3 days post operation
Mood 1-3 days post operation (PANAS) as a mediator of a correlation between serum/plasma concentration of zinc at baseline and cognitive function (global Z score) 1-3 days post operation
Measured: 1-3 days post operation
Mediating influence of mood (PANAS) at follow-up on a correlation between baseline zinc status and cognitive function (global Z score) at follow-up
Mood (PANAS) at follow-up as a mediator of a correlation between concentration of zinc in plasma/serum at baseline and cognitive function (global Z score) at follow-up
Measured: One month post operation
Mediating influence of mood (PANAS) at follow up on a correlation between zinc status and cognitive function (global Z score) at follow-up
Mood (PANAS) at follow up as a mediator of a correlation between concentration of zinc in plasma/serum and cognitive function (global Z score) at follow-up
Measured: One month post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start1 Jan 2021 (estimated)
- Primary completion23 Jun 2021
- Study completion23 Jun 2021
Why it stopped: As a result of Covid-19, this study did not proceed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Berkshire NHS Foundation Trust
- Responsible party
- Principal investigator, Prof Claire Williams, University of Reading
- Investigators
- Claire Williams, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369157
- Sponsor's protocol ID
- RDG-006
- Status last verified
- Jun 2021
- First submitted
- 23 Jan 2020
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only anonymised data will be shared if requested.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Zinc and Inflammation in Susceptibility to Post-operative Cognitive Dysfunction
- ClinicalTrials.gov ID
- NCT04369157
- Acronym / sponsor ID
- RDG-006
- Conditions
- Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: As a result of Covid-19, this study did not proceed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Royal Berkshire NHS Foundation Trust
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 30 Apr 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.
A decline in cognitive abilities following surgery (POCD: Post-Operative Cognitive Dysfunction) affects up to 47% of patients undergoing a surgical procedure. Risk factors include age, previous depression, alcohol and drug use, smoking, cognitive impairment as well as pre-operative biochemical and haematological abnormalities. Inflammation has been proposed as a potential cause, however, there is little empirical and clinical evidence in this area to determine aetiology or reduce risk of incidence.
Zinc is an important metal for brain function, with deficiency associated with poorer cognitive outcomes. In relation to POCD, biomarker studies have revealed that levels of a zinc-alpha-2-glycoprotein (AZGP1) were lower in patients with POCD. AZGP1 is a multifunctional glycoprotein implicated in cell adhesion, immune response, transmembrane transport and cellular proliferation. Microglia, the immune cells of the brain, are highly sensitive to changes in zinc which have been proposed to contribute to neurodegenerative disease as well as POCD. However, whilst animal studies looking at the effects of zinc on cognition have been promising, robust human trials are lacking.
This research aims to establish the role of zinc in POCD by determining associations between zinc status, inflammation, cognitive function, and biomarkers of POCD risk and incidence. This will be achieved by gathering clinical and cognitive data from a sample of older adults undergoing surgery. Blood samples will be taken pre and post-operatively to establish zinc status and plasma concentrations of biomarkers of POCD risk and incidence. Pre and post-operative cognitive assessments will also be conducted to measure memory and executive function. Incidence of POCD will be determined via neurological assessment according to diagnostic criteria.
Should associations between zinc status, POCD biomarkers, inflammation, cognitive performance and POCD incidence be established, not only would it lead to future work to investigate potential mechanisms of action as well as intervention studies looking to support zinc status, optimising early identification of individuals who may be at higher risk of developing POCD should lead to better patient outcomes.
Detailed description
Healthy older adults under-going elective surgery (knee replacement, hip replacement or colorectal surgery) will be recruited via the Royal Berkshire Hospital. Participants will be aged 60 years and above, will have the capacity to give fully informed consent and will be undergoing elective orthopaedic or colorectal surgery.
Participation will involve testing on 3 occasions: 48hours-3 weeks prior to surgery (in the participant's home), 1-3 days post-surgery (in the Royal Berkshire Hospital) and approximately one month post-surgery (in the participant's home).
On each occasion, the Montreal Cognitive Assessment (MoCA) and Confusion Assessment Method (CAM) will be administered along with various cognitive tests measuring executive function (Trials A \& B, Stroop, Letter memory task, verbal fluency) and memory (the episodic memory tests of free recall and recognition from the CERAD: Consortium to Establish a Registry for Alzheimer's Disease neuropsychological test battery), as well as completion of questionnaires to determine mood (the Hospital Anxiety and Depression Scale [HADS] and the Positive and Negative Affect Scale [PANAS]) and sleep quality (the Pittsburgh Sleep Quality Index). The cognitive testing should take approximately 30-40 minutes.
At the first session (pre-operation) only, dietary information will also be collected via a food frequency questionnaire, as well as measures of fluid and crystallised intelligence (the National Adult Reading Test and Block Design from the Wechsler Adult Intelligence Scale - Revised respectively).
In addition, at each visit, a blood sample (maximum volume of 9mL, less than one tablespoon) will be taken from the participants for analysis of zinc concentration and markers of POCD and inflammation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective surgery group | – | Procedure: Elective surgeryPatients undergoing hip/knee replacements or colorectal surgery will be recruited and tested on 3 occasions: pre-op, post-op and at follow-up. POCD status will be determined at post-op and follow up. Cognitive function, zinc status, POCD biomarkers and inflammatory markers will be measured on all 3 occasions. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults aged over 60 years scheduled to undergo elective orthopaedic or colorectal surgery at the Royal Berkshire Hospital
Key inclusion criteria (4 listed)
- Aged 60 years or over
- Able to provide fully informed consent
- Scheduled to undergo orthopaedic (knee/hip replacement) or colorectal surgery
- English as their primary language
Key exclusion criteria (4 listed)
- Under 60 years of age
- Unable to provide fully informed consent
- English not their primary language
- Not electing to undergo any surgery or surgery that is not a knee or hip replacement, or colorectal surgery
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 |
|---|---|---|
| Elective surgeryPatients will be scheduled to undergo elective orthopaedic (knee/hip replacement) or colorectal surgery. | Procedure or surgery | Elective surgery group |
Primary outcome
Baseline zinc status as a predictor of POCD incidence 1-3 days post-operation
Time frame: 1-3 days post operation
Concentration of zinc in plasma/serum at baseline as a predictor for development of POCD 1-3 days post operation
Baseline zinc status as a predictor of POCD incidence at follow-up
Time frame: One month post operation
Concentration of zinc in plasma/serum at baseline as a predictor for development of POCD at follow-up
POCD risk biomarker as a predictor of POCD incidence 1-3 days post operation
Time frame: 1-3 days post operation
Concentration of POCD risk biomarker AZGP1 in plasma/serum at baseline as a predictor for development of POCD 1-3 days post operation
POCD risk biomarker as a predictor of POCD incidence at follow-up
Time frame: One month post operation
Concentration of POCD risk biomarker AZGP1 in plasma/serum at baseline as a predictor for development of POCD at follow-up
Baseline cognitive function (global Z score) as a predictor of POCD incidence 1- 3 days post operation
Time frame: 1-3 days post operation
Baseline cognitive function (global Z score) as a predictor for development of POCD 1-3 days post operation
Baseline cognitive function (global Z score) as a predictor of POCD incidence at follow-up
Time frame: One month post operation
Baseline cognitive function (global Z score) as a predictor for development of POCD at follow-up
22 secondary outcomes
Baseline zinc status as a predictor of cognitive function (global Z score) 1-3 days
Time frame: 1-3 days post operation
Baseline zinc status as a predictor of cognitive function (global Z score) at follow-up
Time frame: One month post operation
Current zinc status and incidence of POCD 1-3 days post operation
Time frame: 1-3 days post operation
Current zinc status and incidence of POCD at follow-up
Time frame: One month post operation
Current zinc status and cognitive function (global Z score) 1-3 days post operation
Time frame: 1-3 days post operation
Current zinc status and cognitive function (global Z score) at follow-up
Time frame: One month post operation
POCD risk biomarker AZGP1 at baseline as predictor of cognitive function (global Z score) 1-3 days post operation
Time frame: 1-3 days post operation
POCD risk biomarker AZGP1 at baseline as predictor of cognitive function (global Z score) at follow-up
Time frame: One month post operation
Correlation between POCD biomarkers (IL-6 and IL-2) 1-3 days post operation and POCD incidence 1-3 days post operation
Time frame: 1-3 days post operation
Correlation between POCD biomarkers (IL-6 and IL-2) at follow-up and POCD incidence at follow-up
Time frame: One month post operation
Correlation between POCD biomarkers (IL-6 and IL-2) 1-3 days post operation and cognitive function (global Z score) 1-3 days post operation
Time frame: 1-3 days post operation
Correlation between POCD biomarkers (IL-6 and IL-2) at follow-up and cognitive function (global Z score) at follow-up
Time frame: One month post operation
Mediating influence of POCD risk biomarker AZGP1 at baseline on a correlation between baseline zinc status and POCD incidence 1-3 days post operation
Time frame: 1-3 days post operation
Mediating influence of POCD risk biomarker AZGP1 at baseline on a correlation between baseline zinc status and POCD incidence at follow-up
Time frame: One month post operation
Mediating influence of POCD risk biomarker AZGP1 at baseline on a correlation between baseline zinc status and cognitive function (global Z score) 1-3 days post operation
Time frame: 1-3 days post operation
Mediating influence of POCD risk biomarker AZGP1 at baseline on a correlation between baseline zinc status and cognitive function (global Z score) at follow-up
Time frame: One month post operation
Mediating influence of POCD biomarkers (IL-6 and IL-2) on a correlation between zinc status and cognitive function (global Z score) 1-3 days post operation
Time frame: 1-3 days post operation
Mediating influence of POCD biomarkers (IL-6 and IL-2) on a correlation between zinc status and cognitive function (global Z score) at follow-up
Time frame: One month post operation
Mediating influence of baseline mood (PANAS) on a correlation between baseline cognitive function (global Z score) and POCD incidence 1-3 days post operation
Time frame: 1-3 days post operation
Mediating influence of mood (PANAS) 1-3 days post operation on a correlation between baseline zinc status and cognitive function (global Z score) 1-3 days post operation
Time frame: 1-3 days post operation
Mediating influence of mood (PANAS) at follow-up on a correlation between baseline zinc status and cognitive function (global Z score) at follow-up
Time frame: One month post operation
Mediating influence of mood (PANAS) at follow up on a correlation between zinc status and cognitive function (global Z score) at follow-up
Time frame: One month post operation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Individual participant dataSharing planned: Yes. Only anonymised data will be shared if requested.
Related trials for Cognitive Dysfunction
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
RecruitingPhase 2
Alzheimer's Tau Platform: Master Protocol
Preclinical Alzheimer's Disease, Alzheimer Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
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.
Claire Williams, PhD principal investigator
University of Reading
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 Cognitive Dysfunction, run by University of Reading at 2 sites in United Kingdom.
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 4 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: withdrawn, as of the sponsor's last update on 29 Jun 2021. 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 United Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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?
Baseline zinc status as a predictor of POCD incidence 1-3 days post-operation (time frame: 1-3 days post operation). 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 29 Jun 2021; AzTrials last refreshed its copy on 27 Oct 2026.