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

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

Sponsors

Lead sponsor: University Hospital, Strasbourg, France

Source University Hospital, Strasbourg, France
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.

Overall Status Unknown status
Start Date April 2013
Completion Date April 2015
Primary Completion Date April 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
rate of alpha-synuclein in cerebrospinal fluid Day one.
Enrollment 265
Condition
Intervention

Intervention type: Other

Intervention name: MRI

Intervention type: Procedure

Intervention name: lumbar puncture

Intervention type: Behavioral

Intervention name: neuropsychological tests

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.

Gender: All

Minimum age: 45 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility status contact investigator Hôpitaux Universitaires de Strasbourg Frédéric BLANC, Docteur 3 88 12 86 38 0033 [email protected] Frédéric BLANC, Docteur Principal Investigator
Location Countries

France

Verification Date

June 2013

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: "Alzheimer's Disease" arm

Arm group type: Other

Description: Patient with Alzheimer's disease

Arm group label: "Lewy Body Disease" arm

Arm group type: Other

Description: Patient with Lewy Body Disease

Acronym AlphaLewyMa
Study Design Info

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov