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

University Hospital, Strasbourg, France

Status: Unknown

Conditions: "Alzheimer's Disease" and "Lewy Body Disease"

Treatments: Procedure: lumbar puncture; Other: MRI; Behavioral: neuropsychological tests

Study type: Interventional

Funder types: Other

Identifiers

NCT01876459

N° IDRCB 2012-A00992-41 (Other Identifier)

5330

Details and patient eligibility

About

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.

Enrollment: 265 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

265 participants in 2 patient groups

"Alzheimer's Disease" arm

Other group

Description:

Patient with Alzheimer's disease

Treatment:

Behavioral: neuropsychological tests

Procedure: lumbar puncture

Other: MRI

"Lewy Body Disease" arm

Other group

Description:

Patient with Lewy Body Disease

Treatment:

Behavioral: neuropsychological tests

Procedure: lumbar puncture

Other: MRI