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

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ClinicalTrials.gov Identifier: NCT01876459
Recruitment Status : Unknown
Verified June 2013 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : June 12, 2013
Last Update Posted : June 18, 2013
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
"Alzheimer's Disease" and "Lewy Body Disease" Other: MRI Procedure: lumbar puncture Behavioral: neuropsychological tests

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 265 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Rate of Alpha-synuclein in Cerebrospinal Fluid to Differentiate Patient With Alzheimer's Disease From Those With Lewy Body Disease.
Study Start Date : April 2013
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2015


Arms and Interventions

Arm Intervention/treatment
"Alzheimer's Disease" arm
Patient with Alzheimer's disease
Other: MRI Procedure: lumbar puncture Behavioral: neuropsychological tests
"Lewy Body Disease" arm
Patient with Lewy Body Disease
Other: MRI Procedure: lumbar puncture Behavioral: neuropsychological tests


Outcome Measures

Primary Outcome Measures :
  1. rate of alpha-synuclein in cerebrospinal fluid [ Time Frame: Day one. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876459


Locations
France
Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, Hôpital de Hautepierre, France, 67098
Contact: Frédéric BLANC, Docteur    3 88 12 86 38 ext 0033    frederic.blanc@chru-strasbourg.fr   
Principal Investigator: Frédéric BLANC, Docteur         
Sponsors and Collaborators
University Hospital, Strasbourg, France
More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01876459     History of Changes
Other Study ID Numbers: 5330
N° IDRCB 2012-A00992-41 ( Other Identifier: ANSM )
First Posted: June 12, 2013    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Alzheimer Disease
Lewy Body Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders