Lewy Body DiseaseDYNAPATH-LBNCT07335692
Dynamical Electrophysiology and Neuropathology in Lewy's Bodies Disease
An observational study of Lewy Body Disease, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Lewy body disease (LBD) is a neurodegenerative disorder that causes cognitive and behavioral problems. However, it is difficult to diagnose, and its pathophysiology is still not fully understood. The usual diagnostic criteria for LBD have excellent specificity but poor sensitivity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lewy Body Disease
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2025to 2 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult subjects (≥18 years old) who participated in the Alpha-Lewy-MA cohort and underwent RT-QuIC analysis and underwent a standard EEG examination at HUS between January 1, 2012, and January 1, 2020.
Who may be able to join
- Adult subjects (≥18 years old).
- Subject who participated in the Alpha-Lewy-MA cohort and underwent RT-QuIC analysis.
- Subject who underwent a standard EEG examination at HUS between January 1, 2012, and January 1, 2020.
Who cannot join
- Subject who expressed opposition to participating in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de psychiatrie de la personne âgée - CHU de Strasbourg - France
Strasbourg, 67091
Ludovic DORMEGNY-JEANJEAN, MD, 33 3 88 11 69 21, ludovic.jeanjean@chru-strasbourg.fr
Ludovic DORMEGNY-JEANJEAN, MD
About this study
Lewy body disease (LBD) is a neurodegenerative disorder that causes cognitive and behavioral problems. However, it is difficult to diagnose, and its pathophysiology is still not fully understood. The usual diagnostic criteria for LBD have excellent specificity but poor sensitivity. In particular, we lack paraclinical tests that can make a significant contribution. LBD patients may exhibit abnormalities in brain activity dynamics, which can be detected by EEG and may be linked to neuronal dysfunctions specific to the disease. The objective of this study is twofold: first, to assess the validity of this observation, that is, to confirm that the observed phenomenon is indeed linked to the pathophysiology of LBD, and second, to clarify the nature of these abnormalities by exploring the brain dynamics of LBD patients in greater detail.
- Conditions
- Lewy Body Disease
- Keywords
- Lewy Body Disease, Neurodegenerative disorder
- Medical subject headings
- Lewy Body Disease, Neurodegenerative Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Parameter θ of dynamic fluidity of brain activity
Parameter θ of dynamic fluidity of brain activity (quantifying the system's ability to move away from its current configuration)
θ is used to measure something specific in the brain: how flexible its activity is.
Quantifying the system's ability to move away from its current configuration:
- In plain words, θ tells us how much the brain can change from its current state.
- High θ → brain is very flexible, can switch between states easily.
- Low θ → brain is rigid, stays in the same pattern longer.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start2 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completion2 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lewy Body DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335692
- Sponsor's protocol ID
- 9691
- Acronym
- DYNAPATH-LB
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamical Electrophysiology and Neuropathology in Lewy's Bodies Disease
- ClinicalTrials.gov ID
- NCT07335692
- Acronym / sponsor ID
- DYNAPATH-LB / 9691
- Conditions
- Lewy Body Disease
- Keywords
- Lewy Body Disease, Neurodegenerative disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- 2 Jun 2026 (estimated)
- First posted
- 13 Jan 2026 (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.
Lewy body disease (LBD) is a neurodegenerative disorder that causes cognitive and behavioral problems. However, it is difficult to diagnose, and its pathophysiology is still not fully understood. The usual diagnostic criteria for LBD have excellent specificity but poor sensitivity. In particular, we lack paraclinical tests that can make a significant contribution. LBD patients may exhibit abnormalities in brain activity dynamics, which can be detected by EEG and may be linked to neuronal dysfunctions specific to the disease. The objective of this study is twofold: first, to assess the validity of this observation, that is, to confirm that the observed phenomenon is indeed linked to the pathophysiology of LBD, and second, to clarify the nature of these abnormalities by exploring the brain dynamics of LBD patients in greater detail.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects (≥18 years old) who participated in the Alpha-Lewy-MA cohort and underwent RT-QuIC analysis and underwent a standard EEG examination at HUS between January 1, 2012, and January 1, 2020.
Key inclusion criteria (3 listed)
- Adult subjects (≥18 years old).
- Subject who participated in the Alpha-Lewy-MA cohort and underwent RT-QuIC analysis.
- Subject who underwent a standard EEG examination at HUS between January 1, 2012, and January 1, 2020.
Key exclusion criteria (1 listed)
- Subject who expressed opposition to participating in the study.
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
Parameter θ of dynamic fluidity of brain activity
Time frame: Up to 12 months
Parameter θ of dynamic fluidity of brain activity (quantifying the system's ability to move away from its current configuration) θ is used to measure something specific in the brain: how flexible its activity is. Quantifying the system's ability to move away from its current configuration: * In plain words, θ tells us how much the brain can change from its current state. * High θ → brain is very flexible, can switch between states easily. * Low θ → brain is rigid, stays in the same pattern longer.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
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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.
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 Lewy Body Disease, run by University Hospital, Strasbourg, France at 1 site in France.
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 3 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: looking for participants now, as of the sponsor's last update on 13 Jan 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ludovic DORMEGNY-JEANJEAN, MD (33 3 88 11 69 21, ludovic.jeanjean@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parameter θ of dynamic fluidity of brain activity (time frame: Up to 12 months). 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 13 Jan 2026.