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.

Study Overview

• Status: Completed
• Conditions: Cognitive Deficits

Detailed Description

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)

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13355
    • Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients and subjects from the Berlin BioCog cohort.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Former BioCog patients; Former BioCog patients from the Berlin study center who have undergone baseline cognitive testing and from whom plasma samples are available
Former BioCog subjects in the non-surgical comparison cohort; Former BioCog subjects in the non-surgical comparison cohort from the Berlin study center who have undergone baseline cognitive testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognitive performance	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.	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance	Acceptance of the CANTAB web-based testing of Cambridge Cognition is measured with a questionnaire.	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Usability	Usability of the CANTAB web-based testing of Cambridge Cognition is measured with a questionnaire.	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
New diagnoses	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.	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Actual medication	Current comedication and supplements	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Charlson Comorbidity index	Comorbidity	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Depression	Depression is measured with Geriatric Depression Scale.	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Weight history	Weight history is measured by weight change in the past 3-6 months.	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Body mass index (BMI)	BMI is a calculated measure of a person's body weight (in kilograms) divided by the square of their height (in meters).	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Mortality	Mortality is measured by the number of deaths.	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
NUcleic acid Linked Immuno-Sandwich Assay Central Nervous System Disease Multiplex Panel	Analysis of 120 proteins.	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Malnutrition Universal Screening Tool (MUST)-Score	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.	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
History of Falls	History of falls is measured with the question: Have you had a fall event within the last year?	Participants will be followed for sequelae at 7-10 years after BioCog study inclusion

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: University Hospital, Bonn; University Hospital Schleswig-Holstein; Universitätsklinikum Essen
• Investigators: Principal Investigator: Claudia Spies, MD, Prof., Charitè - University Berlin

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2025
• Primary Completion (Actual): April 14, 2026
• Study Completion (Actual): April 14, 2026

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders
• Other Study ID Numbers: BioCog-Web

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No