DementiaMES-CoBraDNCT05171725
Multidisciplinary Expert System for the Assessment & Management of Complex Brain Disorders
An observational study of Dementia and Alzheimer Disease, run by Neurological Institute of Athens at 4 sites in 4 countries.
Trial summary
The Multidisciplinary Expert System for the Assessment \& Management of Complex Brain Disorders (MES-CoBraD) is an interdisciplinary project combining Real-World Data (RWD) from multiple clinical and consumer sources through comprehensive, cost-efficient, and fast protocols towards improving diagnostic accuracy and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dementia, Alzheimer Disease, Epilepsy
- What is being tested?
- EEG,PSG, biosample collection (blood and CSF) and neuropsychological testing
- Type of treatment
- Pill or oral medicine
- How many people
- 635 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Apr 2021to 30 Sep 2024
- How long will I take part?
- 3 Years
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study aims to develop an Expert System for the assessment and management of complex brain disorders in real-world practice and participants who present in all of the above clinics are eligible, in order to obtain data as close to real-world practice as possible.
Who may be able to join
- All participants willing to undergo comprehensive assessment who visit one of three clinics (Epilepsy, Neurocognitive disorders, and Sleep Disorders), and healthy volunteers
Who cannot join
- participant disinterest
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
The Multidisciplinary Expert System for the Assessment \& Management of Complex Brain Disorders (MES-CoBraD) is an interdisciplinary project combining Real-World Data (RWD) from multiple clinical and consumer sources through comprehensive, cost-efficient, and fast protocols towards improving diagnostic accuracy and therapeutic outcomes in people with Complex Brain Disorders (CoBraD), as reflected in Neurocognitive (Dementia), Sleep, and Seizure (Epilepsy) disorders and their interdependence. It brings together internationally recognized experts in medicine, engineering, computer science, social health science, law, and marketing and communication from across Europe, and combines clinical information and scientific research in CoBraD with technical innovation in secure data-sharing platforms, artificial intelligence algorithms, and expert systems of precision and personalized care, with a primary focus on improving the quality of life of patients, their caregivers, and the society at large. It leverages RWD from diverse CoBraD populations across cultural, socioeconomic, educational, and health system backgrounds, with special attention on including vulnerable populations and minorities in an equitable manner and engaging key stakeholders to maximize project impact.
- Conditions
- Dementia, Alzheimer Disease, Epilepsy, Sleep Disorder, Circadian Rhythm Disorders, Healthy
- Being tested
- EEG,PSG, biosample collection (blood and CSF), neuropsychological testing, actigraphy, clinician assessment
- Keywords
- artificial intelligence, expert systems, deep-phenotyping
- Medical subject headings
- Dementia, Alzheimer Disease, Epilepsy, Sleep Wake Disorders, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG,PSGDiagnostic test
concurrent overnight sleep study with full electroencephalography (in-lab or at home)
biosample collection (blood and CSF)Diagnostic test
blood or CSF collection for analyses of neurodegenerative, inflammatory, and, per condition, genetic information
neuropsychological testingDiagnostic test
paper and pencil, as well as tablet based cognitive testing
actigraphyDiagnostic test
week long actigraphy assessment with concurrent sleep diary acquisition
clinician assessmentDiagnostic test
standard clinical assessment by an expert clinician in the respective field of brain disorders
| Study group | Role | What they receive |
|---|---|---|
| Sleep and Circadian Disorders | Observational deep phenotyping of people presenting with Sleep and Circadian disorders. Participants will undergo a comprehensive multidisciplinary protocol of clinical assessment by an expert clinician, neuropsychological testing by a neuropsychologist through paper-and-pencil and tablet tests, actigraphy, polysomnography with concurrent electroencephalography, pre- and post- sleep cognitive testing and biosample acquisition, and where available provide access to wearable data, therapeutic device data (e.g., PAP/NIV), and brain imaging Receives: Diagnostic Test: EEG,PSG; Diagnostic Test: biosample collection (blood and CSF); Diagnostic Test: neuropsychological testing; Diagnostic Test: actigraphy; Diagnostic Test: clinician assessment | |
| Neurocognitive Disorders | Observational deep phenotyping of people presenting with Dementia (including Alzheimer's disease, vascular disease, frontotemporal dementia). Participants will undergo a comprehensive multidisciplinary protocol of clinical assessment by an expert clinician, neuropsychological testing by a neuropsychologist through paper-and-pencil and tablet tests, actigraphy, polysomnography with concurrent electroencephalography, pre- and post- sleep cognitive testing and biosample acquisition, and where available provide access to wearable data, therapeutic device data (e.g., PAP/NIV), and brain imaging Receives: Diagnostic Test: EEG,PSG; Diagnostic Test: biosample collection (blood and CSF); Diagnostic Test: neuropsychological testing; Diagnostic Test: actigraphy; Diagnostic Test: clinician assessment | |
| Epilepsy disorders | Observational deep phenotyping of people presenting with seizures and Epilepsy disorder. Participants will undergo a comprehensive multidisciplinary protocol of clinical assessment by an expert clinician, neuropsychological testing by a neuropsychologist through paper-and-pencil and tablet tests, actigraphy, polysomnography with concurrent electroencephalography, pre- and post- sleep cognitive testing and biosample acquisition, and where available provide access to wearable data, therapeutic device data (e.g., PAP/NIV), and brain imaging Receives: Diagnostic Test: EEG,PSG; Diagnostic Test: biosample collection (blood and CSF); Diagnostic Test: neuropsychological testing; Diagnostic Test: actigraphy; Diagnostic Test: clinician assessment | |
| Healthy controls | Participants will undergo a comprehensive multidisciplinary protocol of clinical assessment by an expert clinician, neuropsychological testing by a neuropsychologist through paper-and-pencil and tablet tests, actigraphy, polysomnography with concurrent electroencephalography, pre- and post- sleep cognitive testing and biosample acquisition, and where available provide access to wearable data, therapeutic device data (e.g., PAP/NIV), and brain imaging Receives: Diagnostic Test: EEG,PSG; Diagnostic Test: biosample collection (blood and CSF); Diagnostic Test: neuropsychological testing; Diagnostic Test: actigraphy; Diagnostic Test: clinician assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expert System Accuracy for the Assessment of Complex Brain Disorders
Pursuing external cross-validation using training and test sample data acquired during MES-CoBraD, examine the sensitivity, specificity, accuracy, and likelihood ratios in making an accurate diagnosis of Complex Brain Disorders (neurocognitive, epilepsy, sleep disorders), compared to gold standard diagnostic criteria.
Measured: 3 years
Expert System Accuracy for the Management of Complex Brain Disorders
Pursuing external cross-validation using training and test sample data acquired during MES-CoBraD, examine the sensitivity, specificity, accuracy, and likelihood ratios in recommending standard of care treatment decisions in Complex Brain Disorders (neurocognitive, epilepsy, sleep disorders), compared to gold standard professional society recommendations.
Measured: 3 years
Secondary outcomes (3)
Examine safety of approved therapies for Complex Brain Disorders
Test for statistically significant Side-Effect differences within 6 months of initiating approved treatments for Complex Brain Disorders between participants receiving and not receiving disease-specific therapies. Side effect reporting will be combined from patient, caregiver, and clinician input. Side effects are defined by a combination of predefined common and significant side-effect options and free text.
Measured: 3 years
Prevalence co-occurrence of Complex Brain Disorders (Neurocognitive, Sleep, and Epilepsy disorders)
Within each of the three types of CoBraD, examine the frequency of comorbidity of the other two following comprehensive diagnostic protocols
Measured: 3 years
Examine efficacy of approved therapies for Complex Brain Disorders
Test for statistically significant efficacy differences of using approved treatments for Complex Brain Disorders over the 3 year period of the study, between participants receiving and not receiving disease-specific therapies post sample stratification. Efficacy data will be combined from patient, caregiver, and clinician input according to the respective CoBraD efficacy outcome measures (e.g., MoCA for neurocognitive, seizure frequency and severity for epilepsy, PSQI for sleep disorders).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start1 Apr 2021
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 635 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Neurological Institute of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Rabin Medical Center, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, King's College London, Uppsala University, Holistic IKE, National Technical University of Athens, Evolution Projects, Engineering Ingegneria Informatica S.p.A., SOFTWARE IMAGINATION & VISION SRL, Vrije Universiteit Brussel, STICHTING LIBER, University of Edinburgh, CyberEthics Lab. srls
- Responsible party
- Sponsor
- Investigators
- Elissaios Karageorgiou, Study director, Neurological Institute of AthensIoannis Stavropoulos, Study director, King's College LondonOphir Keret, Study director, Rabin Medical CenterJuan Fortea, Study director, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171725
- Sponsor's protocol ID
- EU-Horizon-2020-965422
- Acronym
- MES-CoBraD
- Status last verified
- Mar 2026
- First submitted
- 30 Sep 2021
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be anonymized and depersonalized on a local site repository, and then uploaded in the secure MES-CoBraD Platform. An estimated six months after study completion, data will be made available to other researchers through the MES-CoBraD Platform.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Expert System for the Assessment & Management of Complex Brain Disorders
- ClinicalTrials.gov ID
- NCT05171725
- Acronym / sponsor ID
- MES-CoBraD / EU-Horizon-2020-965422
- Conditions
- Dementia, Alzheimer Disease, Epilepsy, Sleep Disorder, Circadian Rhythm Disorders, Healthy
- Keywords
- artificial intelligence, expert systems, deep-phenotyping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 635 participants (actual)
- Lead sponsor
- Neurological Institute of AthensUniversity, hospital or other
- Collaborators
- Rabin Medical Center, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, King's College London, Uppsala University, Holistic IKE, National Technical University of Athens, Evolution Projects, Engineering Ingegneria Informatica S.p.A., SOFTWARE IMAGINATION & VISION SRL, Vrije Universiteit Brussel, STICHTING LIBER, University of Edinburgh, CyberEthics Lab. srls
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 29 Dec 2021 (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.
The Multidisciplinary Expert System for the Assessment \& Management of Complex Brain Disorders (MES-CoBraD) is an interdisciplinary project combining Real-World Data (RWD) from multiple clinical and consumer sources through comprehensive, cost-efficient, and fast protocols towards improving diagnostic accuracy and therapeutic outcomes in people with Complex Brain Disorders (CoBraD), as reflected in Neurocognitive (Dementia), Sleep, and Seizure (Epilepsy) disorders and their interdependence. It brings together internationally recognized experts in medicine, engineering, computer science, social health science, law, and marketing and communication from across Europe, and combines clinical information and scientific research in CoBraD with technical innovation in secure data-sharing platforms, artificial intelligence algorithms, and expert systems of precision and personalized care, with a primary focus on improving the quality of life of patients, their caregivers, and the society at large. It leverages RWD from diverse CoBraD populations across cultural, socioeconomic, educational, and health system backgrounds, with special attention on including vulnerable populations and minorities in an equitable manner and engaging key stakeholders to maximize project impact.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sleep and Circadian Disorders | – | Diagnostic Test: EEG,PSG, Diagnostic Test: biosample collection (blood and CSF), Diagnostic Test: neuropsychological testing, Diagnostic Test: actigraphy, Diagnostic Test: clinician assessmentObservational deep phenotyping of people presenting with Sleep and Circadian disorders. Participants will undergo a comprehensive multidisciplinary protocol of clinical assessment by an expert clinician, neuropsychological testing by a neuropsychologist through paper-and-pencil and tablet tests, actigraphy, polysomnography with concurrent electroencephalography, pre- and post- sleep cognitive testing and biosample acquisition, and where available provide access to wearable data, therapeutic device data (e.g., PAP/NIV), and brain imaging |
| Neurocognitive Disorders | – | Diagnostic Test: EEG,PSG, Diagnostic Test: biosample collection (blood and CSF), Diagnostic Test: neuropsychological testing, Diagnostic Test: actigraphy, Diagnostic Test: clinician assessmentObservational deep phenotyping of people presenting with Dementia (including Alzheimer's disease, vascular disease, frontotemporal dementia). Participants will undergo a comprehensive multidisciplinary protocol of clinical assessment by an expert clinician, neuropsychological testing by a neuropsychologist through paper-and-pencil and tablet tests, actigraphy, polysomnography with concurrent electroencephalography, pre- and post- sleep cognitive testing and biosample acquisition, and where available provide access to wearable data, therapeutic device data (e.g., PAP/NIV), and brain imaging |
| Epilepsy disorders | – | Diagnostic Test: EEG,PSG, Diagnostic Test: biosample collection (blood and CSF), Diagnostic Test: neuropsychological testing, Diagnostic Test: actigraphy, Diagnostic Test: clinician assessmentObservational deep phenotyping of people presenting with seizures and Epilepsy disorder. Participants will undergo a comprehensive multidisciplinary protocol of clinical assessment by an expert clinician, neuropsychological testing by a neuropsychologist through paper-and-pencil and tablet tests, actigraphy, polysomnography with concurrent electroencephalography, pre- and post- sleep cognitive testing and biosample acquisition, and where available provide access to wearable data, therapeutic device data (e.g., PAP/NIV), and brain imaging |
| Healthy controls | – | Diagnostic Test: EEG,PSG, Diagnostic Test: biosample collection (blood and CSF), Diagnostic Test: neuropsychological testing, Diagnostic Test: actigraphy, Diagnostic Test: clinician assessmentParticipants will undergo a comprehensive multidisciplinary protocol of clinical assessment by an expert clinician, neuropsychological testing by a neuropsychologist through paper-and-pencil and tablet tests, actigraphy, polysomnography with concurrent electroencephalography, pre- and post- sleep cognitive testing and biosample acquisition, and where available provide access to wearable data, therapeutic device data (e.g., PAP/NIV), and brain imaging |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study aims to develop an Expert System for the assessment and management of complex brain disorders in real-world practice and participants who present in all of the above clinics are eligible, in order to obtain data as close to real-world practice as possible.
Key inclusion criteria (1 listed)
- All participants willing to undergo comprehensive assessment who visit one of three clinics (Epilepsy, Neurocognitive disorders, and Sleep Disorders), and healthy volunteers
Key exclusion criteria (1 listed)
- participant disinterest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG,PSGconcurrent overnight sleep study with full electroencephalography (in-lab or at home) | Diagnostic test | Epilepsy disorders, Healthy controls, Neurocognitive Disorders, Sleep and Circadian Disorders |
| biosample collection (blood and CSF)blood or CSF collection for analyses of neurodegenerative, inflammatory, and, per condition, genetic information | Diagnostic test | Epilepsy disorders, Healthy controls, Neurocognitive Disorders, Sleep and Circadian Disorders |
| neuropsychological testingpaper and pencil, as well as tablet based cognitive testing | Diagnostic test | Epilepsy disorders, Healthy controls, Neurocognitive Disorders, Sleep and Circadian Disorders |
| actigraphyweek long actigraphy assessment with concurrent sleep diary acquisition | Diagnostic test | Epilepsy disorders, Healthy controls, Neurocognitive Disorders, Sleep and Circadian Disorders |
| clinician assessmentstandard clinical assessment by an expert clinician in the respective field of brain disorders | Diagnostic test | Epilepsy disorders, Healthy controls, Neurocognitive Disorders, Sleep and Circadian Disorders |
Primary outcome
Expert System Accuracy for the Assessment of Complex Brain Disorders
Time frame: 3 years
Pursuing external cross-validation using training and test sample data acquired during MES-CoBraD, examine the sensitivity, specificity, accuracy, and likelihood ratios in making an accurate diagnosis of Complex Brain Disorders (neurocognitive, epilepsy, sleep disorders), compared to gold standard diagnostic criteria.
Expert System Accuracy for the Management of Complex Brain Disorders
Time frame: 3 years
Pursuing external cross-validation using training and test sample data acquired during MES-CoBraD, examine the sensitivity, specificity, accuracy, and likelihood ratios in recommending standard of care treatment decisions in Complex Brain Disorders (neurocognitive, epilepsy, sleep disorders), compared to gold standard professional society recommendations.
3 secondary outcomes
Examine safety of approved therapies for Complex Brain Disorders
Time frame: 3 years
Prevalence co-occurrence of Complex Brain Disorders (Neurocognitive, Sleep, and Epilepsy disorders)
Time frame: 3 years
Examine efficacy of approved therapies for Complex Brain Disorders
Time frame: 3 years
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 2 Apr 2026.
- Study siteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be anonymized and depersonalized on a local site repository, and then uploaded in the secure MES-CoBraD Platform. An estimated six months after study completion, data will be made available to other researchers through the MES-CoBraD Platform.
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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.
Elissaios Karageorgiou study director
Neurological Institute of Athens
Ioannis Stavropoulos study director
King's College London
Ophir Keret study director
Rabin Medical Center
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Alzheimer Disease, run by Neurological Institute of Athens at 4 sites in 4 countries.
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 1 inclusion and 1 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 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Greece, Israel, Spain, United Kingdom. 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?
Expert System Accuracy for the Assessment of Complex Brain Disorders (time frame: 3 years). The study lists 2 primary outcomes in all. 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 2 Apr 2026.