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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01876459
First received: June 10, 2013
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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 Intervention
"Alzheimer's Disease" and "Lewy Body Disease"
Other: MRI
Procedure: lumbar puncture
Behavioral: neuropsychological tests

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • rate of alpha-synuclein in cerebrospinal fluid [ Time Frame: Day one. ] [ Designated as safety issue: No ]

Estimated Enrollment: 265
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
"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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01876459     History of Changes
Other Study ID Numbers: 5330, N° IDRCB 2012-A00992-41
Study First Received: June 10, 2013
Last Updated: June 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on October 22, 2014