Influence of Age on Amyloid Load in Alzheimer's Disease and in Atypical Focal Cortical Alzheimer's Disease (BIOMAGE)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- measuring the rate of cortical brain atrophy,
- FDG imaging of glucose metabolism reflecting neuronal activity, and
- 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 |
- 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.
- 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 |
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
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| France | |
| Pitie Salpêtrière Hospital | |
| Paris, Ile de France, France, 75651 | |
| 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 May 19, 2013