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

Alzheimer's Disease Clinical Trial

— BIOMAGE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095744
• Other study ID #: C08-30
• Secondary ID: 2008-A00939-46
• Status: Completed
• Phase: N/A
• First received: March 12, 2010
• Last updated: October 8, 2012
• Start date: March 2009
• Est. completion date: May 2012

Study information

• Verified date: February 2012
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Direction Générale de la SantéFrance: Institutional Ethical Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Aphasia
• Atrophy
• Logopenic Progressive Aphasia
• Posterior Cortical Atrophy

Locations

Country	Name	City	State
France	Pitie Salpêtrière Hospital	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PIB-PET imaging of amyloid load	PET imaging using PIB radio-tracer will give an estimation of regional amyloid load for every patient	0 - 2 months	No
Primary	FDG-PET imaging of glucose metabolism	PET imaging using 18F-fluorodesoxyglucose (FDG) will give a visualization of regional neuronal metabolism	0 - 2 months	No
Primary	clinical phenotypic assessment	the clinical evaluation includes a neurologic consulting, a neuropsychologic assessment of cognitive performances, and evaluation of autonomy	0 - 2 months	No
Primary	MRI	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.	0 - 2 months	No
Primary	ApoE gene sequencing	ApoE gene sequencing, will be performed after all samples have been collected. So this may be 0 to 24 month after inclusion.	0 - 24 months after inclusion	No
Secondary	amyloid and Tau measurements in cerebro-spinal fluid (csf)	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.	-6 months or +6months arround T0	No