Back to resultsTruncated and Extended Forms of Amyloid Beta Peptides in Alzheimer's Disease: Genesis, Toxicity and Identification as Biological Markers
Primary Purpose
Alzheimer Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Alzhamyd
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- 1) Coming subjects to see patients in CMRR for a complaint mnésique 2) Introducing a score in Tiny Mental the upper Test (MMSE) in 28/30 without error in under score of the recall of the 3 words 3) Introducing a score of 10/10 in the test of the 5 words of B2C 4) Introducing a score in the ladder CDR (Clinical Dementia Rating) equal to 0 5) Having given a lit consent 6) Being affiliated member or beneficiary of the regime of French national health and pensions organization
Exclusion Criteria:
- Major, all the vulnerable persons under 18 under tutelage, under legal guardianship, deprived of freedom, hospitalized in a health Establishment or social for quite other reason that searches it
- Record of neurological or psychiatric pathology and inability for sensory reasons to perform a cognitive balance sheet
Sites / Locations
- RobertRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Group Alzhamyd
Arm Description
The patients coming in consultation for a mnésique complaint will see each other offering the study. During a consultation, the following balance sheet will be accomplished :clinical Maintenance, collection of records and used treatments psycho-behaviour Valuation through Neuropsychiatric Inventory (NPI) and through Inventory Apathy Valuation of self-government in the activities of daily life (IADL). Further to this balance sheet, it is habitually offered on the subjects of advice (principally centered on the proposals of use of external helps for instance book memo, agenda and internal assistants medium notes-techniques and associations to keep information) and a new consultation 1 year afterwards including the same balance sheet. In a supplementary way in this clinical valuation, a blood sample will be accomplished at the time of inclusion and 12 months afterwards.
Outcomes
Primary Outcome Measures
Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.
Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.
Secondary Outcome Measures
The availability of truncated fragments designed to set up monoclonal antibodies will allow us to estimate their associated toxicity in various cellular models.
Secondly, the availability of truncated fragments designed to set up monoclonal antibodies will allow us to estimate their associated toxicity in various cellular models. Furthermore, we will be able to compare the toxicity of soluble monomers and aggregates. Third, we expect to determine the content of these Ab species in the biological fluids of various representative non-demented or AD affected patients.
Full Information
NCT ID
NCT01128725
First Posted
May 21, 2010
Last Updated
March 23, 2012
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01128725
Brief Title
Truncated and Extended Forms of Amyloid Beta Peptides in Alzheimer's Disease: Genesis, Toxicity and Identification as Biological Markers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Beta amyloid immunoreactivity is probably due to a significant number of Ab catabolites corresponding to N-terminally truncated and Cterminally truncated or extended forms which display distinct propensity to aggregation. Very few things are known concerning the mechanisms and proteases by which they are generated. Furthermore, the link between truncation and toxicity has not been delineated.
Finally, little is known concerning Ab fragments in biological fluids and whether they could be seen as early biomarkers and thereby, as putative targets for AD diagnostic. The present project will allow to examine the human biological samples and to identify various cohorts after complete clinical evaluation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group Alzhamyd
Arm Type
Other
Arm Description
The patients coming in consultation for a mnésique complaint will see each other offering the study. During a consultation, the following balance sheet will be accomplished :clinical Maintenance, collection of records and used treatments
psycho-behaviour Valuation through Neuropsychiatric Inventory (NPI) and through Inventory Apathy
Valuation of self-government in the activities of daily life (IADL). Further to this balance sheet, it is habitually offered on the subjects of advice (principally centered on the proposals of use of external helps for instance book memo, agenda and internal assistants medium notes-techniques and associations to keep information) and a new consultation 1 year afterwards including the same balance sheet.
In a supplementary way in this clinical valuation, a blood sample will be accomplished at the time of inclusion and 12 months afterwards.
Intervention Type
Other
Intervention Name(s)
Alzhamyd
Intervention Description
The patients coming in consultation for a mnésique complaint will see each other offering the study. During a consultation, the following balance sheet will be accomplished :clinical Maintenance, collection of records and used treatments
psycho-behaviour Valuation through Neuropsychiatric Inventory (NPI) and through Inventory Apathy
Valuation of self-government in the activities of daily life (IADL). Further to this balance sheet, it is habitually offered on the subjects of advice (principally centered on the proposals of use of external helps for instance book memo, agenda and internal assistants medium notes-techniques and associations to keep information) and a new consultation 1 year afterwards including the same balance sheet.
In a supplementary way in this clinical valuation, a blood sample will be accomplished at the time of inclusion and 12 months afterwards.
Primary Outcome Measure Information:
Title
Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.
Description
Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.
Time Frame
one year
Secondary Outcome Measure Information:
Title
The availability of truncated fragments designed to set up monoclonal antibodies will allow us to estimate their associated toxicity in various cellular models.
Description
Secondly, the availability of truncated fragments designed to set up monoclonal antibodies will allow us to estimate their associated toxicity in various cellular models. Furthermore, we will be able to compare the toxicity of soluble monomers and aggregates. Third, we expect to determine the content of these Ab species in the biological fluids of various representative non-demented or AD affected patients.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1) Coming subjects to see patients in CMRR for a complaint mnésique 2) Introducing a score in Tiny Mental the upper Test (MMSE) in 28/30 without error in under score of the recall of the 3 words 3) Introducing a score of 10/10 in the test of the 5 words of B2C 4) Introducing a score in the ladder CDR (Clinical Dementia Rating) equal to 0 5) Having given a lit consent 6) Being affiliated member or beneficiary of the regime of French national health and pensions organization
Exclusion Criteria:
Major, all the vulnerable persons under 18 under tutelage, under legal guardianship, deprived of freedom, hospitalized in a health Establishment or social for quite other reason that searches it
Record of neurological or psychiatric pathology and inability for sensory reasons to perform a cognitive balance sheet
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe ROBERT, PhD
Phone
+33492034770
Ext
+334920347
Email
robert.p@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe ROBERT
Organizational Affiliation
CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06001
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe ROBERT, PhD
Phone
+33492034770
Ext
+33492034772
Email
robert.p@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Philippe ROBERT, PhD
12. IPD Sharing Statement
Learn more about this trial
Truncated and Extended Forms of Amyloid Beta Peptides in Alzheimer's Disease: Genesis, Toxicity and Identification as Biological Markers
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