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

Alzheimer's Disease and Lewy Body Disease Clinical Trial

— AlphaLewyMa  

Official title:

Rate of Alpha-synuclein in Cerebrospinal Fluid to Differentiate Patient With Alzheimer's Disease From Those With Lewy Body Disease.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01876459
• Other study ID #: 5330
• Secondary ID: N° IDRCB 2012-A0
• Status: Recruiting
• Phase: N/A
• First received: June 10, 2013
• Last updated: June 17, 2013
• Start date: April 2013
• Est. completion date: April 2015

Study information

• Verified date: June 2013
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 265
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease and Lewy Body Disease
• Lewy Body Disease

Intervention

Other:
• MRI

Procedure:
• lumbar puncture

Behavioral:
• neuropsychological tests

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg	Strasbourg	Hôpital de Hautepierre

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of alpha-synuclein in cerebrospinal fluid		Day one.	No