NCT07335692

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
0mo left

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Jun 2025Jun 2026

Study Start

First participant enrolled

June 2, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2026

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

January 2, 2026

Last Update Submit

January 2, 2026

Conditions

Keywords

Lewy Body DiseaseNeurodegenerative disorder

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • \- Subject who expressed opposition to participating in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de psychiatrie de la personne âgée - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Lewy Body DiseaseNeurodegenerative Diseases

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaMovement DisordersSynucleinopathiesNeurocognitive DisordersMental Disorders

Central Study Contacts

Ludovic DORMEGNY-JEANJEAN, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 13, 2026

Study Start

June 2, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 2, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations