New Biomarker for Alzheimer's Disease Diagnostic (BALTAZAR)

This study is currently recruiting participants.
Verified June 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01315639
First received: March 11, 2011
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

The aim of this study is to examine the relationship between plasma putative biomarkers for Alzheimer's disease (i.e. Ab40 amyloid and total Ab42 amyloid, free, bound, free/bound, truncated, sAPPα) and :

  • the risk of conversion of individuals with Mild Cognitive Impairment (MCI) into Alzheimer's disease (AD),
  • the Alzheimer's disease progression rate.

Condition
Alzheimer's Disease
Mild Cognitive Impairment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Plasma Abeta Peptides and the Risk of Alzheimer's Disease. Diagnostic Performance and Predictive and Prognostic Values of Measurements of Plasma Amyloid Peptides Concentrations for the Diagnosis of Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Mean concentration of plasma AB peptides [ Time Frame: at t0 and 24 months ] [ Designated as safety issue: No ]
    • MCI "converted" (MCI-AD)
    • and stable MCI (MCI-MCI) groups


Secondary Outcome Measures:
  • Mean concentration of biomarker [ Time Frame: t0 and 24 months ] [ Designated as safety issue: No ]
    • Mean plasma concentration of AB peptides between

      • fast decliner AD (decline of 7 points or more in ADAS-cog)
      • and non fast decliner AD groups
    • Mean concentration of sAPPalpha between

      • MCI "converted" (MCI-AD)
      • and stable MCI (MCI-MCI) groups
    • Mean concentration of sAPPalpha between

      • fast decliner AD (decline of 7 points or more in ADAS-cog)
      • and non fast decliner AD groups

  • MRI [ Time Frame: T0 ] [ Designated as safety issue: No ]
    •Relationship between MRI measures (brain volume, hippocampus atrophy, vascular lesions) and biomarkers

  • Transcriptomics biomarkers [ Time Frame: T0 and 24 months ] [ Designated as safety issue: No ]
    • Relationship between transcriptomics biomarkers and cognitive decline

  • Ancillary study [ Time Frame: every 6 months ] [ Designated as safety issue: No ]

    • Oculomotor tests between

    • MCI "converted" (MCI-AD)
    • and stable MCI (MCI-MCI) groups
    • fast decliner AD (decline of 7 points or more in ADAS-cog)
    • and non fast decliner AD groups

  • MRI (ancillary study) [ Time Frame: T0 ] [ Designated as safety issue: No ]
    • Relationship between MRI measures (brain volume, hippocampus atrophy, vascular lesions) and oculomotor tests score


Biospecimen Retention:   Samples With DNA

blood samples CSF samples


Estimated Enrollment: 820
Study Start Date: August 2010
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Alzheimer's disease cohort

Longitudinal multicenter study including 820 subjects with amnestic impairment (MCI, n=410 and AD, n=410) derived from the main French national Memory Resources and Research Centers.

Participants will undergo at baseline and every 6 months a neurological examination, a neuropsychological assessment (and an oculomotor examination for those included from Broca Hospital).

Alzheimer disease biomarkers' measurements will be performed at inclusion and at the end of the study.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Longitudinal multicenter study including 820 subjects with amnestic impairment (MCI, n=410 and AD, n=410) derived from the main French national Memory Resources and Research Centers.

Criteria

Inclusion Criteria:

MCI group :

  • ≥ 70 years
  • MCI diagnosis : New criteria (Petersen, PORTET*)

    1. cognitive complaint from the patient, family, or both,
    2. report by the subject or reporter of a decline in cognitive or functional performance, relative to previous abilities,
    3. cognitive disorders evidenced by clinical evaluation: impairment in memory or another cognitive domain,
    4. cognitive impairment without any repercussion on daily life, even if the subject reports difficulties concerning complex daily activities,
    5. no dementia
  • Having signed an informed consent form
  • Fluent in French

AD group :

  • ≥ 45 years
  • AD diagnosis (DSM IV-TR et NINCDS-ADRDA)
  • Mild to moderate (MMSE > 15)
  • Having signed an informed consent form
  • Caregiver/informant to provide information on patient

Exclusion Criteria:

  • Normal cognitive function
  • Major depression (according to the DSMIV-TR or MINI or Geriatric depression Scale> 20/30)
  • Genetic form of AD (genetic mutation known)
  • All other diseases that could interfere with cognitive assessment (Epilepsy, Parkinson's disease, schizophrenia, other dementia)
  • Major sensory deficits that could interfere with cognitive assessment (visual and auditory)
  • Diseases involving the short-term survival (advanced cancer, unstable heart disease, severe hepatic/respiratory/renal failure)
  • Contraindication for MRI, for lumbar puncture (i.e. anticoagulant agents)
  • Use of any experimental agent for the duration of the study
  • Participation to other biomedical research that could interfere with principal objective of the study
  • For MCI patient, use of IchE or memantine medication before inclusion
  • Less than 4 years of education
  • Illiteracy, is unable to count or to read
  • Being under guardianship
  • Pregnant women
  • Non health insurance affiliation
  • Private subjects of freedom by legal or administrative decision
  • Contraindication for MRI examination:
  • Claustrophobic subject
  • Carrying a cardiac pacemaker
  • Presence of any ferromagnetic metallic implants or foreign bodies (carrying an internal electrical/magnetic device, carrying a valvular prosthesis)
  • Carrying a ventricular valvular

Exclusion criteria specific to the lumbar puncture:

• Taking anticoagulant agents

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315639

Contacts
Contact: Olivier Hanon, MD, PhD 0033144083502 olivier.hanon@brc.aphp.fr
Contact: Raphael SERREAU, MD, PhD 0033158411180 raphael.serreau@cch.aphp.fr

Locations
France
APHP, Hôpital Broca Recruiting
Paris, France, 75013
Principal Investigator: Olivier Hanon, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Olivier Hanon, ph Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01315639     History of Changes
Other Study ID Numbers: P081205
Study First Received: March 11, 2011
Last Updated: June 5, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Dementia
Cognitive impairment
Memory impairment
Mild Cognitive Impairment
Cerebrospinal fluid
Plasma
Biomarker
Longitudinal
Abeta peptide amyloid, saPP alpha
Oculomotor impairment

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
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 April 16, 2014