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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06716528
Enrollment
76
Registered
2024-12-04
Start date
2025-01-07
Completion date
2026-04-14
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Deficits

Brief summary

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.

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)

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER
University Hospital, Bonn
CollaboratorOTHER
University Hospital Schleswig-Holstein
CollaboratorOTHER
Universitätsklinikum Essen
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in cognitive performanceParticipants will be followed for sequelae at 7-10 years after BioCog study inclusionThe 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

MeasureTime frameDescription
AcceptanceParticipants will be followed for sequelae at 7-10 years after BioCog study inclusionAcceptance of the CANTAB web-based testing of Cambridge Cognition is measured with a questionnaire.
UsabilityParticipants will be followed for sequelae at 7-10 years after BioCog study inclusionUsability of the CANTAB web-based testing of Cambridge Cognition is measured with a questionnaire.
NUcleic acid Linked Immuno-Sandwich Assay Central Nervous System Disease Multiplex PanelParticipants will be followed for sequelae at 7-10 years after BioCog study inclusionAnalysis of 120 proteins.
New diagnosesParticipants will be followed for sequelae at 7-10 years after BioCog study inclusionLast 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.
Actual medicationParticipants will be followed for sequelae at 7-10 years after BioCog study inclusionCurrent comedication and supplements
Charlson Comorbidity indexParticipants will be followed for sequelae at 7-10 years after BioCog study inclusionComorbidity
History of FallsParticipants will be followed for sequelae at 7-10 years after BioCog study inclusionHistory of falls is measured with the question: Have you had a fall event within the last year?
DepressionParticipants will be followed for sequelae at 7-10 years after BioCog study inclusionDepression is measured with Geriatric Depression Scale.
Weight historyParticipants will be followed for sequelae at 7-10 years after BioCog study inclusionWeight history is measured by weight change in the past 3-6 months.
Malnutrition Universal Screening Tool (MUST)-ScoreParticipants will be followed for sequelae at 7-10 years after BioCog study inclusionAdd 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.
Body mass index (BMI)Participants will be followed for sequelae at 7-10 years after BioCog study inclusionBMI is a calculated measure of a person's body weight (in kilograms) divided by the square of their height (in meters).
MortalityParticipants will be followed for sequelae at 7-10 years after BioCog study inclusionMortality is measured by the number of deaths.

Countries

Germany

Contacts

PRINCIPAL_INVESTIGATORClaudia Spies, MD, Prof.

Charitè - University Berlin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026