Cognitive Fraility and Biomarkers in Older Patients | NCT07184073

Studies
Cognitive Fraility and Biomarkers in Older Patients

NCT07184073

Sponsor

Baskent University

Status

Completed

Last Update Posted

Sep 19, 2025Actual

Enrollment

129Actual

Phase

Not provided

Conditions

Cognitive Impairment
Frail Older Adults
Orthopaedic Surgery

Interventions

assessment Mini mental state examination
assessment FRAIL scale
collecting cerebrospinal fluid during regional anesthesia

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 3, 2021Actual

Primary Completion Date

Sep 4, 2022Actual

Completion Date

Sep 4, 2022Actual

First Submitted Date

Sep 13, 2025

First Submission Date that Met QC Criteria

Sep 13, 2025

First Posted Date

Sep 19, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2025

Last Update Posted Date

Sep 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

129Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
age 65-74			Behavioral: assessment Mini mental state examination Behavioral: assessment FRAIL scale Other: collecting cerebrospinal fluid during regional anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
assessment Mini mental state examination	Behavioral	pre operatively four weeks postoperatively	age 65-74

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between biomarkers of neurodegeneration and preoperative frailty, cognitive function?	p<0,05 was accepted as statistically significant	preoperatively and four weeks postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA 1-3 patients
>65 age patients

Exclusion Criteria:

history of psychiatric or neurological disease
uncontrolled hypertension
alchohol dependence
renal failure
active liver disease
cancer-related or emergency surgery
unwillingness to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

patients aged 65 years or older who underwent elective major lower extremity orthopedic surgery under regional anesthesia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baskent University Ankara Hospital		Ankara			Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	Fang et al. BMC Geriatrics (2024) 24:851

ID	Term
D060825	Cognitive Dysfunction
C537987	Charcot-Marie-Tooth disease, Type 1F

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders

ID	Term
D009483	Neuropsychological Tests
D011581	Psychological Tests
D004191	Behavioral Disciplines and Activities