Alpha-synuclein in Cerebrospinal Fluid to Differentiate Alzheimer's Disease From Lewy Body Disease.

NCT ID: NCT01876459

Last Updated: 2013-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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"Alzheimer's Disease" arm

Patient with Alzheimer's disease

Group Type OTHER

MRI

Intervention Type OTHER

lumbar puncture

Intervention Type PROCEDURE

neuropsychological tests

Intervention Type BEHAVIORAL

"Lewy Body Disease" arm

Patient with Lewy Body Disease

Group Type OTHER

MRI

Intervention Type OTHER

lumbar puncture

Intervention Type PROCEDURE

neuropsychological tests

Intervention Type BEHAVIORAL

Interventions

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MRI

Intervention Type OTHER

lumbar puncture

Intervention Type PROCEDURE

neuropsychological tests

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpitaux Universitaires de Strasbourg

Strasbourg, Hôpital de Hautepierre, France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Frédéric BLANC, Docteur

Role: primary

3 88 12 86 38 ext. 0033

References

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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 Oct 17:13872877251386844. doi: 10.1177/13872877251386844. Online ahead of print.

Reference Type DERIVED
PMID: 41105629 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40011213 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39080741 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37653269 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33300151 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32993772 (View on PubMed)

Other Identifiers

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N° IDRCB 2012-A00992-41

Identifier Type: OTHER

Identifier Source: secondary_id

5330

Identifier Type: -

Identifier Source: org_study_id

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