CClinicalTrials.gg
Status unknownNCT01128725Updated Mar 26, 2012

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

An interventional study of Alzhamyd in Alzheimer Disease, sponsored by Centre Hospitalier Universitaire de Nice. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-26.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified May 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer Disease

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 100 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    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

Interventions

  • OtherAlzhamyd

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: one year

Secondary outcomes

  1. 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.

    Time frame: one year

07

Study locations

1 of 1 sites recruiting
  • Robert
    Nice, Alpes-Maritimes 06001, France
    • Philippe ROBERT, PhD · Contact · robert.p@chu-nice.fr · +33492034770
    • Philippe ROBERT, PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01128725
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
May 24, 2010
Start date
Sep 2010
Primary completion
Sep 2010
Completion
Dec 2012 (estimated)
Last update
Mar 26, 2012

Study contacts

Philippe ROBERT, PhD
Contact
robert.p@chu-nice.fr
+33492034770 ext. +334920347
Philippe ROBERT
principal investigator · CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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