Truncated and Extended Forms of Amyloid Beta Peptides in Alzheimer's Disease: Genesis, Toxicity and Identification as Biological Markers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01128725
First received: May 21, 2010
Last updated: March 23, 2012
Last verified: May 2010
  Purpose

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.


Condition Intervention
Alzheimer Disease
Other: Alzhamyd

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

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. [ Time Frame: one year ] [ Designated as safety issue: No ]
    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. [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group Alzhamyd

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.

Other: Alzhamyd

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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01128725

Contacts
Contact: Philippe ROBERT, PhD +33492034770 ext +334920347 robert.p@chu-nice.fr

Locations
France
Robert Recruiting
Nice, Alpes-Maritimes, France, 06001
Contact: Philippe ROBERT, PhD    +33492034770 ext +33492034772    robert.p@chu-nice.fr   
Principal Investigator: Philippe ROBERT, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Philippe ROBERT CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01128725     History of Changes
Other Study ID Numbers: 10-PP-01
Study First Received: May 21, 2010
Last Updated: March 23, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014