Alpha-synuclein in Cerebrospinal Fluid to Differentiate Alzheimer's Disease From Lewy Body Disease. (AlphaLewyMa)
Primary Purpose
"Alzheimer's Disease" and "Lewy Body Disease"
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
lumbar puncture
neuropsychological tests
Sponsored by
About this trial
This is an interventional diagnostic trial for "Alzheimer's Disease" and "Lewy Body Disease"
Eligibility Criteria
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.
Sites / Locations
- Hôpitaux Universitaires de StrasbourgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
"Alzheimer's Disease" arm
"Lewy Body Disease" arm
Arm Description
Patient with Alzheimer's disease
Patient with Lewy Body Disease
Outcomes
Primary Outcome Measures
rate of alpha-synuclein in cerebrospinal fluid
Secondary Outcome Measures
Full Information
NCT ID
NCT01876459
First Posted
June 10, 2013
Last Updated
June 17, 2013
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT01876459
Brief Title
Alpha-synuclein in Cerebrospinal Fluid to Differentiate Alzheimer's Disease From Lewy Body Disease.
Acronym
AlphaLewyMa
Official Title
Rate of Alpha-synuclein in Cerebrospinal Fluid to Differentiate Patient With Alzheimer's Disease From Those With Lewy Body Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
"Alzheimer's Disease" and "Lewy Body Disease"
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
265 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
"Alzheimer's Disease" arm
Arm Type
Other
Arm Description
Patient with Alzheimer's disease
Arm Title
"Lewy Body Disease" arm
Arm Type
Other
Arm Description
Patient with Lewy Body Disease
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Type
Procedure
Intervention Name(s)
lumbar puncture
Intervention Type
Behavioral
Intervention Name(s)
neuropsychological tests
Primary Outcome Measure Information:
Title
rate of alpha-synuclein in cerebrospinal fluid
Time Frame
Day one.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
State/Province
Hôpital de Hautepierre
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric BLANC, Docteur
Phone
3 88 12 86 38
Ext
0033
Email
frederic.blanc@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Frédéric BLANC, Docteur
12. IPD Sharing Statement
Citations:
PubMed Identifier
33300151
Citation
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.
Results Reference
derived
PubMed Identifier
32993772
Citation
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.
Results Reference
derived
Learn more about this trial
Alpha-synuclein in Cerebrospinal Fluid to Differentiate Alzheimer's Disease From Lewy Body Disease.
We'll reach out to this number within 24 hrs