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

June 17, 2013 updated by: University Hospital, Strasbourg, France

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

265

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Hôpital de Hautepierre
      • Strasbourg, Hôpital de Hautepierre, France, 67098
        • Recruiting
        • Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Principal Investigator:
          • Frédéric BLANC, Docteur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of alpha-synuclein in cerebrospinal fluid
Time Frame: Day one.
Day one.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

June 10, 2013

First Submitted That Met QC Criteria

June 11, 2013

First Posted (Estimate)

June 12, 2013

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5330
  • N° IDRCB 2012-A00992-41 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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