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

NCT06716528 | Recruiting

• 1 other identifier: BioCog-Web
• Study Type: observational
• Target: 434
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Deficits

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Acceptance

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

• Usability

  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

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

• New diagnoses

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

• Actual medication

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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients and subjects from the Berlin BioCog cohort.

You may qualify if:

• 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.

You may not qualify if:

• None
• Subjects
• BioCog subjects of the non-operated comparison cohort from Berlin with cognitive testing (CANTAB Research Suite) at baseline who are contactable
• None

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• University Hospital, Bonn: collaborator
• University Hospital Schleswig-Holstein: collaborator
• Universitätsklinikum Essen: collaborator

Study Sites (1)

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

Berlin, 13355, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Proteomics is emerging as a vital tool in identifying biomarkers of neurodegenerative disease progression and response to therapy. The NUcleic acid Linked Immuno-Sandwich Assay (NULISA)-Seq™ Central Nervous System Disease Panel 120 provides best-in-class sensitivity and robust, multiplexed analysis of 120 neuro-specific and inflammatory proteins from 10 µl of plasma.

MeSH Terms

Conditions

Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Study Officials

• Claudia Spies, MD, Prof.

  Charitè - University Berlin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Spies, MD, Prof.

CONTACT

+49 30 450 551102; claudia.spies@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: January 7, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)