Influence of Age on Amyloid Load in Alzheimer's Disease and in Atypical Focal Cortical Alzheimer's Disease (BIOMAGE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01095744
First received: March 12, 2010
Last updated: October 8, 2012
Last verified: February 2012
  Purpose

The first objective is to asses influence of age on amyloid load measured by PET imaging using Pittsburgh B compound (PiB) radio-tracer, in Alzheimer's disease(AD). This will allow the determination of brains age-specific deterioration factors by comparing Early onset AD (EOAD), Late onset AD (LOAD)and atypical focal cortical AD (PCA and LPA). The amount of brain lesions in AD patients is estimated by:

  1. measuring the rate of cortical brain atrophy,
  2. FDG imaging of glucose metabolism reflecting neuronal activity, and
  3. for patients who benefited from a lumbar puncture; Cortical-spinal fluid (CSF) amounts of amyloïd and tau proteins are measured.

Condition
Alzheimer's Disease
Posterior Cortical Atrophy
Logopenic Progressive Aphasia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Influence of Age on amyloïd Load in Alzheimer's Disease and in Atypical Focal Cortical Alzheimer's Disease Like Posterior Cortical Atrophy (PCA) and Logopenic Progressive Aphasia (LPA)Using Positron Emitting Tomography (PET) Imaging

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • PIB-PET imaging of amyloid load [ Time Frame: 0 - 2 months ] [ Designated as safety issue: No ]
    PET imaging using PIB radio-tracer will give an estimation of regional amyloid load for every patient

  • FDG-PET imaging of glucose metabolism [ Time Frame: 0 - 2 months ] [ Designated as safety issue: No ]
    PET imaging using 18F-fluorodesoxyglucose (FDG) will give a visualization of regional neuronal metabolism

  • clinical phenotypic assessment [ Time Frame: 0 - 2 months ] [ Designated as safety issue: No ]
    the clinical evaluation includes a neurologic consulting, a neuropsychologic assessment of cognitive performances, and evaluation of autonomy

  • MRI [ Time Frame: 0 - 2 months ] [ Designated as safety issue: No ]
    the magnetic resonance imaging will be performed using numerous modalities like T1 weighted sequences for anatomic information, T2 weighted FLAIR and TSE sequences to avoid vascular injuries and T2 GRE to avoid microbleeds, DTI for the diffusion tensor imaging and default mode FMRI, to identify neural networks involved in default concious mode.

  • ApoE gene sequencing [ Time Frame: 0 - 24 months after inclusion ] [ Designated as safety issue: No ]
    ApoE gene sequencing, will be performed after all samples have been collected. So this may be 0 to 24 month after inclusion.


Secondary Outcome Measures:
  • amyloid and Tau measurements in cerebro-spinal fluid (csf) [ Time Frame: -6 months or +6months arround T0 ] [ Designated as safety issue: No ]
    some patients have a lumbar puncture that allows a direct quantification of CSF amyloid, tau and phospho-tau amounts.This measure is performed in the 6 months following the clinical assessment (at inclusion) and when a former puncture has already been done, it can be used retro-actively up to 6 months before clinical assessment.


Biospecimen Retention:   Samples With DNA

DNA sample immortalized blood cell cultures csf aliquots for patients who beneficiated from a lumbar puncture.


Enrollment: 60
Study Start Date: March 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
EOAD typical AD
this cohort is constituted with early onset typical AD.
LOAD typical
this group is constituted with late onset typical AD
atypical AD
this group is constituted with atypical form of focal cortical atrophy, like posterior cortical atrophy and logopenic progressive aphasia.
young controls
under 65
old controls
over 65

Detailed Description:

Literature data suggests there are different types of AD depending on their age of onset, called EOAD and LOAD. These two categories are distinguished by the localization of brain atrophy : severe and 'posterior' in EOAD and more 'anterior' in LOAD. Neuro-pathologic data suggests some atypical focal cortical atrophy, characterized by a respect of episodic memory, may be classified within EOAD.

PiB-based PET imaging allows the in-vivo visualization and quantification of amyloïd load.

We want to answer the question whether the amount of amyloïd protein may be lower in LOAD than EOAD in patients showing the same level of dementia, and thus identify ageing-specific cognitive disorders and understand witch factors influence etio-pathology of typical and atypical Alzheimer's disease.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients have to fulfil criteria for (1)AD with an amnesic syndrome of the media-temporal type, EOAD have lower frequency and (2) and for atypical Ad respecting episodic memory, inaugural language disorder or visual-spatial disorder

Criteria

Inclusion Criteria:

  • AD patients: clinical dementia rating between 0.5 and 2 free and cued recall test (Grober and Buschke) cued-recall < 18/48 and total recall < 40/48
  • atypical AD : i visual-spatial disorder and respect of episodic memory progressive evolution, Balint syndrome ii progressive language disorder constituted of logopenic aphasia respect of episodic memory
  • controls: age over 30 MMSE over or equal to 27 normal neuropsychiatric state for age and education level

Exclusion Criteria:

  • for every patients : psychiatric disorders age under18 absence of social security counter indication to MRI supposed or actual alcoholism or drug addiction pregnancy
  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: NCT01095744

Locations
France
Pitie Salpêtrière Hospital
Paris, Ile de France, France, 75651
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Bruno Dubois, professor doctor INSERM U975
Study Chair: marie c sarzin, doctor Inserm U975
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01095744     History of Changes
Other Study ID Numbers: C08-30, 2008-A00939-46
Study First Received: March 12, 2010
Last Updated: October 8, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Direction Générale de la Santé
France: Institutional Ethical Committee

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
PIB imaging,
brain atrophy
cognitive impairment
Pet imaging
Alzheimer's disease
amyloid protein

Additional relevant MeSH terms:
Alzheimer Disease
Aphasia
Atrophy
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 28, 2014