Cognitive DeficitsNCT06716528
Web-based Application to Test for Long-term Cognitive Deficits in BioCog Patients
An observational study of Cognitive Deficits, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Deficits
- How many people
- 76 participants
- Where
- 1 siteGermany
- Study dates
- 7 Jan 2025to 14 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients and subjects from the Berlin BioCog cohort.
Who may be able to join
- 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.
- -BioCog subjects of the non-operated comparison cohort from Berlin with cognitive testing (CANTAB Research Suite) at baseline who are contactable
Who cannot join
- None
- Subjects
- -None
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin
Berlin, 13355
About this study
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.
Read the 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)
- Conditions
- Cognitive Deficits
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Secondary outcomes (12)
Acceptance
Acceptance of the CANTAB web-based testing of Cambridge Cognition is measured with a questionnaire.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Actual medication
Current comedication and supplements
Measured: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Charlson Comorbidity index
Comorbidity
Measured: 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?
Measured: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Depression
Depression is measured with Geriatric Depression Scale.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Mortality
Mortality is measured by the number of deaths.
Measured: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start7 Jan 2025
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeficitsStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bonn, University Hospital Schleswig-Holstein, Universitätsklinikum Essen
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Principal investigator, Charitè - University Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716528
- Sponsor's protocol ID
- BioCog-Web
- Status last verified
- Jun 2026
- First submitted
- 29 Nov 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Application to Test for Long-term Cognitive Deficits in BioCog Patients
- ClinicalTrials.gov ID
- NCT06716528
- Acronym / sponsor ID
- BioCog-Web
- Conditions
- Cognitive Deficits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- University Hospital, Bonn, University Hospital Schleswig-Holstein, Universitätsklinikum Essen
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients and subjects from the Berlin BioCog cohort.
Key inclusion criteria (4 listed)
- 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.
- -BioCog subjects of the non-operated comparison cohort from Berlin with cognitive testing (CANTAB Research Suite) at baseline who are contactable
Key exclusion criteria (3 listed)
- None
- Subjects
- -None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
12 secondary outcomes
Acceptance
Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Usability
Time frame: 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
Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
New diagnoses
Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Actual medication
Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Charlson Comorbidity index
Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
History of Falls
Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Depression
Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Weight history
Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Malnutrition Universal Screening Tool (MUST)-Score
Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Body mass index (BMI)
Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Mortality
Time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. principal investigator
Charitè - University Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Deficits, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive performance (time frame: Participants will be followed for sequelae at 7-10 years after BioCog study inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.