Cognitive ImpairmentNCT07184073
Cognitive Fraility and Biomarkers in Older Patients
An observational study of Cognitive Impairment and Frail Older Adults, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
this study aimed to investigate the association between cognitive fraility and selected plasma and cerebrospinal fluid biomarkers related to neurodegenetaion and neuroinflammation in older adult patients undergoing elective orthopedic surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairment, Frail Older Adults, Orthopaedic Surgery
- What is being tested?
- assessment Mini mental state examination, assessment FRAIL scale and collecting cerebrospinal fluid during regional anesthesia
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 129 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2021to 4 Sep 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: patients aged 65 years or older who underwent elective major lower extremity orthopedic surgery under regional anesthesia
Who may be able to join
- ASA 1-3 patients
- >65 age patients
Who cannot join
- history of psychiatric or neurological disease
- uncontrolled hypertension
- alchohol dependence
- renal failure
- active liver disease
- cancer-related or emergency surgery
- unwillingness to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Cognitive Fraility and Blood and CSF Biomarkers in Older Orthopedic Patients Under Regional Anesthesia
this study aimed to investigate the association between cognitive fraility and selected plasma and cerebrospinal fluid biomarkers related to neurodegenetaion and neuroinflammation in older adult patients undergoing elective orthopedic surgery.
The main questions it aims to answer is:
- Can biomarkers indicating neurodegeneration and neuroinflammation be correlated with preoperative frailty and cognitive functions?
- Can these biomarkers be used as potential tools for early identification in vulnarable populations?
Read the detailed description
It is a cross sectional study
- Being tested
- assessment Mini mental state examination, assessment FRAIL scale, collecting cerebrospinal fluid during regional anesthesia
- Keywords
- cognitive frailty, neurofilament light chain, cerebrospinal fluid biomarkers, older adult patients, orthopedic surgery
- Medical subject headings
- Cognitive Dysfunction, Charcot-Marie-Tooth disease, Type 1F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment Mini mental state examinationBehavioural
pre operatively four weeks postoperatively
assessment FRAIL scaleBehavioural
pre operatively four weeks postoperatively
collecting cerebrospinal fluid during regional anesthesiaOther
In the operating room regional anesthesia was administered according to the surgical plan
| Study group | Role | What they receive |
|---|---|---|
| age 65-74 | Not described Receives: Behavioral: assessment Mini mental state examination; Behavioral: assessment FRAIL scale; Other: collecting cerebrospinal fluid during regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between biomarkers of neurodegeneration and preoperative frailty, cognitive function?
p<0,05 was accepted as statistically significant
Measured: preoperatively and four weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start3 Jun 2021
- Primary completion4 Sep 2022
- Study completion4 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ELVIN KESIMCI, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184073
- Sponsor's protocol ID
- KA21/124
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fang et al. BMC Geriatrics (2024) 24:851
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Cognitive Fraility and Blood and CSF Biomarkers in Older Orthopedic Patients Under Regional Anesthesia
- ClinicalTrials.gov ID
- NCT07184073
- Acronym / sponsor ID
- KA21/124
- Keywords
- cognitive frailty, neurofilament light chain, cerebrospinal fluid biomarkers, older adult patients, orthopedic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 4 Sep 2022 (actual)
- Study completion
- 4 Sep 2022 (actual)
- First posted
- 19 Sep 2025 (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 aimed to investigate the association between cognitive fraility and selected plasma and cerebrospinal fluid biomarkers related to neurodegenetaion and neuroinflammation in older adult patients undergoing elective orthopedic surgery.
The main questions it aims to answer is:
- Can biomarkers indicating neurodegeneration and neuroinflammation be correlated with preoperative frailty and cognitive functions?
- Can these biomarkers be used as potential tools for early identification in vulnarable populations?
Detailed description
It is a cross sectional study
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| age 65-74 | – | Behavioral: assessment Mini mental state examination, Behavioral: assessment FRAIL scale, Other: collecting cerebrospinal fluid during regional anesthesia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- patients aged 65 years or older who underwent elective major lower extremity orthopedic surgery under regional anesthesia
Key inclusion criteria (2 listed)
- ASA 1-3 patients
- >65 age patients
Key exclusion criteria (7 listed)
- history of psychiatric or neurological disease
- uncontrolled hypertension
- alchohol dependence
- renal failure
- active liver disease
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 |
|---|---|---|
| assessment Mini mental state examinationpre operatively four weeks postoperatively | Behavioural | age 65-74 |
| assessment FRAIL scalepre operatively four weeks postoperatively | Behavioural | age 65-74 |
| collecting cerebrospinal fluid during regional anesthesiaIn the operating room regional anesthesia was administered according to the surgical plan | Other | age 65-74 |
Primary outcome
Correlation between biomarkers of neurodegeneration and preoperative frailty, cognitive function?
Time frame: preoperatively and four weeks postoperatively
p<0,05 was accepted as statistically significant
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 19 Sep 2025.
- Results publicationFang et al. BMC Geriatrics (2024) 24:851
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Frail Older Adults, run by Baskent University at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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 19 Sep 2025. 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 Turkey (Türkiye). 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?
Correlation between biomarkers of neurodegeneration and preoperative frailty, cognitive function? (time frame: preoperatively and four weeks postoperatively). 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 NCT07184073, which also lists 1 linked publication.
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 19 Sep 2025.