NCT01876459

Brief Summary

Patients with memory disorders are experiencing different trends which are difficult to predict. Moreover, the distinction between Lewy body disease and Alzheimer's disease is not easy as both diseases can present similar symptoms. Nowadays, routine examinations exist and can improve the diagnosis but there are not specific enough of one of those two pathologies. Lewy body disease is characterized by the presence of particular structures in patient's brain, called "Lewy body", composed of a protein called "alpha-synuclein". The aim of this study is to measure the rate of alpha-synuclein in cerebrospinal fluid. This measurement could allow us to differentiate patient with Alzheimer's disease from those with Lewy body disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
265

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

2 years

First QC Date

June 10, 2013

Last Update Submit

June 17, 2013

Conditions

"Alzheimer's Disease" and "Lewy Body Disease"

Outcome Measures

Primary Outcomes (1)

  • rate of alpha-synuclein in cerebrospinal fluid

    Day one.

Study Arms (2)

"Alzheimer's Disease" arm

OTHER

Patient with Alzheimer's disease

Other: MRIProcedure: lumbar punctureBehavioral: neuropsychological tests

"Lewy Body Disease" arm

OTHER

Patient with Lewy Body Disease

Other: MRIProcedure: lumbar punctureBehavioral: neuropsychological tests

Interventions

MRIOTHER
"Alzheimer's Disease" arm"Lewy Body Disease" arm
lumbar puncturePROCEDURE
"Alzheimer's Disease" arm"Lewy Body Disease" arm
neuropsychological testsBEHAVIORAL
"Alzheimer's Disease" arm"Lewy Body Disease" arm

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 45 years of age
  • Subject agrees to participate in the study
  • Subject meets the criteria Dubois et al., 2007. for diagnosis of probable AD.
  • Subject with a syndromic presentation of mild cognitive impairment or mild dementia
  • Subject has a study partner who is able to provide accurate information about the patient
  • Subject affiliated to a social security scheme

You may not qualify if:

  • Patient who meets both AD and Lewy Body disease criteria
  • Contraindications to lumbar puncture
  • Contraindications to an MRI scan
  • Subject who is not affiliated to a social security scheme
  • Subject under guardianship or curatorship
  • Subject under judicial protection
  • Subject refuses to participate in the study
  • Subject has evidence of clinically relevant neurological disorder (fronto-temporal dementia, brain tumor, stroke, …) that led to persistent cognitive disorders
  • Subject has evidence of clinically relevant psychiatric disorders (schizophrenia, major depression, …)
  • Pregnant or attempting to become pregnant women
  • Subject's vision and audition is sufficient for neuropsychological tests's assessment, based on the investigator's judgment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, Hôpital de Hautepierre, 67098, France

RECRUITING

Related Publications (6)

  • Gabriel V, Chabran E, Sourty M, Cretin B, Philippi N, Muller C, Anthony P, Demuynck C, Loureiro de Sousa P, Botzung A, Sanna L, Bousiges O, Blanc F. Salience and frontoparietal network impairments across disease stages in dementia with Lewy bodies: A comparative functional MRI study with Alzheimer's disease. J Alzheimers Dis. 2025 Dec;108(3):1398-1409. doi: 10.1177/13872877251386844. Epub 2025 Oct 17.

    PMID: 41105629DERIVED

  • Querry M, Botzung A, Sourty M, Chabran E, Sanna L, Loureiro de Sousa P, Cretin B, Demuynck C, Muller C, Ravier A, Schorr B, Philippi N, Blanc F. Functional Connectivity Changes Associated With Depression in Dementia With Lewy Bodies. Int J Geriatr Psychiatry. 2025 Mar;40(3):e70058. doi: 10.1002/gps.70058.

    PMID: 40011213DERIVED

  • Sainsily-Cesarus A, Schmitt E, Landre L, Botzung A, Rauch L, Demuynck C, Philippi N, de Sousa PL, Mutter C, Cretin B, Martin-Hunyadi C, Blanc F. Dementia with Lewy bodies and gait neural basis: a cross-sectional study. Alzheimers Res Ther. 2024 Jul 30;16(1):170. doi: 10.1186/s13195-024-01539-z.

    PMID: 39080741DERIVED

  • Bousiges O, Cretin B, Muller C, Botzung A, Sanna L, Anthony P, Philippi N, Demuynck C, Blanc F. Involvement of ApoE4 in dementia with Lewy bodies in the prodromal and demented stages: evaluation of the Strasbourg cohort. Geroscience. 2024 Apr;46(2):1527-1542. doi: 10.1007/s11357-023-00883-6. Epub 2023 Aug 31.

    PMID: 37653269DERIVED

  • Mendes A, Noblet V, Mondino M, Loureiro de Sousa P, Manji S, Archenault A, Casanovas M, Bousiges O, Philippi N, Baloglu S, Rauch L, Cretin B, Demuynck C, Martin-Hunyadi C, Blanc F. Association of cerebral microbleeds with cerebrospinal fluid Alzheimer-biomarkers and clinical symptoms in early dementia with Lewy bodies. Int J Geriatr Psychiatry. 2021 Jun;36(6):851-857. doi: 10.1002/gps.5485. Epub 2020 Dec 26.

    PMID: 33300151DERIVED

  • Bousiges O, Philippi N, Lavaux T, Perret-Liaudet A, Lachmann I, Schaeffer-Agalede C, Anthony P, Botzung A, Rauch L, Jung B, de Sousa PL, Demuynck C, Martin-Hunyadi C, Cretin B, Blanc F. Differential diagnostic value of total alpha-synuclein assay in the cerebrospinal fluid between Alzheimer's disease and dementia with Lewy bodies from the prodromal stage. Alzheimers Res Ther. 2020 Sep 29;12(1):120. doi: 10.1186/s13195-020-00684-5.

    PMID: 32993772DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseLewy Body Disease

Interventions

Spinal PunctureNeuropsychological Tests

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathies

Intervention Hierarchy (Ancestors)

BiopsySpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative TechniquesPsychological TestsBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 12, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

FR(1)