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Completed

NCT Number: NCT06716528

Web-based Application to Test for Long-term Cognitive Deficits in BioCog Patients

In the present study, a long-term cognitive follow-up of participants of the BioCog cohort (data collection period 2014 - 2019, Ethical vote No: EA2/092/14) from the Berlin study center is to be will be performed in order to record long-term cognitive sequelae (7 to 10 years after study inclusion). In addition to a medical telephone/video visit, the follow-up includes the collection of cognitive tests via web applications and questionnaires of acceptance and usability in the home environment. The study data are analysed in cooperation with the University of Bonn, University Medical Center Schleswig-Holstein and the University of Essen.

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Key information

Conditions

Cognitive Deficits Cognition Disorders Mental Disorders Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin

Berlin, 13355, Germany

About this study

The primary research objective is the exploratory investigation of changes in cognitive test performance as well as cognitive self-care and functionality in former BioCog patients and BioCog subjects in the non-surgical comparison cohort in the long-term follow-up (7 - 10 years) compared to the baseline survey (from the BioCog main study).The primary question is operationalized in several ways:

  • according to the International Statistical Classification of Diseases and Related Health Problems(ICD-10) classification system
  • according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) classification system
  • computer-based, online and independently conducted cognitive testing using Cantab Web based testing from Cambridge Cognition
  • Cognitive self-care using Geriatric depression Scale item 10
  • Cognitive self-care with Multifactorial Memory Questionnaire
  • Cognitive other-care with The Informant Questionnaire on Cognitive Decline in the Elderly questionnaire
  • Functionality with Activities of Daily Living (ADLs) & Instrumental Activities of Daily Living (IADLs) questionnaire
  • Additionally: Quality of life with 5-level EQ-5D version (EQ-5D-5L)

Evaluation by Mild Cognitive Impairment Algorithm of the University Clinic Bonn (research group Prof. Wagner).

Evaluation by mild/major Neurocognitive Disorder (NCD) algorithm of Charité - University Medicine Berlin (research group Prof. Spies)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients

Inclusion criteria

  • Patients of Berliner BioCog cohort with cognitive Testing (CANTAB Research Suite) at Baseline and with plasma samples for baseline that can be contacted.
  • Written informed consent for participation in the BioCog-Web study.
  • Data and reserve samples from patients in the Berlin BioCog cohort who can no longer be contacted.

Exclusion criteria

  • None

Subjects

Inclusion Criterion:

-BioCog subjects of the non-operated comparison cohort from Berlin with cognitive testing (CANTAB Research Suite) at baseline who are contactable

Exclusion criteria

-None

Treatment and study plan

Primary outcomes

  1. Change in cognitive performance

    Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion

    The primary object of research is the explorative investigation of the change in cognitive test performance as well as cognitive self-care and functionality in the long-term follow-up (7 - 10 years) compared to the baseline survey (from the main BioCog study). It is measured with CANTAB Research Suite, CANTAB web-based testing and paper pencil tests.

Secondary outcomes

  1. Acceptance

    Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion

    Acceptance of the CANTAB web-based testing of Cambridge Cognition is measured with a questionnaire.

  2. Usability

    Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion

    Usability of the CANTAB web-based testing of Cambridge Cognition is measured with a questionnaire.

  3. NUcleic acid Linked Immuno-Sandwich Assay Central Nervous System Disease Multiplex Panel

    Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion

    Analysis of 120 proteins.

  4. New diagnoses

    Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion

    Last doctor's letter/last findings (especially in the case of neurological/psychiatric/geriatric connections - e.g. memory consultation) for recording new diagnoses and recording the last outpatient and/or inpatient treatments.

  5. Actual medication

    Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion

    Current comedication and supplements

  6. Charlson Comorbidity index

    Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion

    Comorbidity

  7. History of Falls

    Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion

    History of falls is measured with the question: Have you had a fall event within the last year?

  8. Depression

    Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion

    Depression is measured with Geriatric Depression Scale.

  9. Weight history

    Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion

    Weight history is measured by weight change in the past 3-6 months.

  10. Malnutrition Universal Screening Tool (MUST)-Score

    Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion

    Add Scores together to calculate overall risk of malnutrition with the Malnutrition screening tool: Score 0 corresponds to low risk; Score 1 corresponds to medium risk; Score 2 or more corresponds to high risk.

  11. Body mass index (BMI)

    Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion

    BMI is a calculated measure of a person's body weight (in kilograms) divided by the square of their height (in meters).

  12. Mortality

    Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion

    Mortality is measured by the number of deaths.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • University Hospital Schleswig-Holstein
  • University Hospital, Bonn
  • Universitätsklinikum Essen

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2024
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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