NL-OMON44903
Completed
Not Applicable
Biomarker Development for Postoperative Cognitive Impairment in the Elderly - BioCog
Charite Berlijn0 sites500 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Charite Berlijn
- Enrollment
- 500
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male and female participants aged 65 years or older,
- •2\. Ability to give informed consent after verbal and written information,
- •3\. European ancestry (up till grandparents) for homogeneity reasons for the molecular and genetic investigations.
- •Patients also need to meet the following criteria:
- •4\. Undergoing elective surgery,
- •5\. Planned operation time \> 60 minutes.
Exclusion Criteria
- •1\. MMSE score \* 23,
- •2\. Planned intracranial operation,
- •3\. Any medical (e.g., vision or hearing) or (neuro)psychiatric condition that would make neuropsychological and/or neuroimaging testing impossible,
- •4\. Claustrophobia or other reasons (e.g., large tattoos) that make the participant unsuitable to undergo MRI investigations,
- •5\. Homelessness or other circumstances where the patient would not be reachable by phone or postal services during follow\-up,
- •6\. Participation in an intervention study during study participation,
- •7\. Admission under judicial or official orders,
- •8\. Life expectancy less than 1 year,
- •9\. Withdrawal of informed consent to store, use and distribute pseudomized data which will be gathered during the clinical study period.
- •Control participants additionally will be excluded if the following criterion applies:
Outcomes
Primary Outcomes
Not specified
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