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

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Charité University Medicine Berlin

Status

Enrolling

Conditions

Cognitive Deficits

Study type

Observational

Funder types

Other

Identifiers

NCT06716528
BioCog-Web

Details and patient eligibility

About

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.

Full 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)

Enrollment

434 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Exclusion criteria:

-None

Trial design

434 participants in 2 patient groups

Former BioCog patients
Description:
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
Description:
Former BioCog subjects in the non-surgical comparison cohort from the Berlin study center who have undergone baseline cognitive testing

Trial contacts and locations

1

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Central trial contact

Claudia Spies, MD, Prof.

Data sourced from clinicaltrials.gov

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