Multi-modal Neuroimaging in Alzheimer's Disease

NCT ID: NCT01554202

Last Updated: 2013-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

295 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Brief Summary

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According to estimations, Alzheimer's disease affects approximately 860,000 people aged of more than 65 years in France. This disease is characterized by disorders of cognitive functions, including memory, associated with structural and functional modifications of the brain. These changes are evolving within the pathology progression and can be evaluated with neuropsychological tests (to assess capabilities such as language, orientation, etc.) and also with brain imaging (e.g. MRI). Alzheimer's disease is still poorly understood, nevertheless currently available treatments can slow its development if the disease is diagnosed early enough.

Thus, the objective is to identify markers for early diagnosis of Alzheimer's disease, to better describe the evolution of this disease.

The three main objectives of this project are

* to identify, compare and combine predictive markers of Alzheimer's disease
* to make a significant contribution to the understanding of the pathophysiological mechanisms of Alzheimer's disease
* to study the ability of different neuroimaging techniques to follow the evolution of this pathology.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Young controls

Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Group Type EXPERIMENTAL

assessment of memory

Intervention Type BEHAVIORAL

circulating tPA dosage

Intervention Type BIOLOGICAL

ApoE4

Intervention Type GENETIC

Brain imaging examination MRI and PET examinations

Intervention Type OTHER

Middle age controls

Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Group Type EXPERIMENTAL

assessment of memory

Intervention Type BEHAVIORAL

circulating tPA dosage

Intervention Type BIOLOGICAL

ApoE4

Intervention Type GENETIC

Brain imaging examination MRI and PET examinations

Intervention Type OTHER

Elderly controls

Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Group Type EXPERIMENTAL

assessment of memory

Intervention Type BEHAVIORAL

circulating tPA dosage

Intervention Type BIOLOGICAL

ApoE4

Intervention Type GENETIC

Brain imaging examination MRI and PET examinations

Intervention Type OTHER

Autosomal dominant forms of early-onset Alzheimer disease

Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Group Type EXPERIMENTAL

assessment of memory

Intervention Type BEHAVIORAL

circulating tPA dosage

Intervention Type BIOLOGICAL

ApoE4

Intervention Type GENETIC

Brain imaging examination MRI and PET examinations

Intervention Type OTHER

Subjectif Cognitive Impariment patients

Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Group Type EXPERIMENTAL

assessment of memory

Intervention Type BEHAVIORAL

circulating tPA dosage

Intervention Type BIOLOGICAL

ApoE4

Intervention Type GENETIC

Brain imaging examination MRI and PET examinations

Intervention Type OTHER

Mild Cognitive Impairment patients

Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Group Type EXPERIMENTAL

assessment of memory

Intervention Type BEHAVIORAL

circulating tPA dosage

Intervention Type BIOLOGICAL

ApoE4

Intervention Type GENETIC

Brain imaging examination MRI and PET examinations

Intervention Type OTHER

Alzheimer Disease patients

Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Group Type EXPERIMENTAL

assessment of memory

Intervention Type BEHAVIORAL

circulating tPA dosage

Intervention Type BIOLOGICAL

ApoE4

Intervention Type GENETIC

Brain imaging examination MRI and PET examinations

Intervention Type OTHER

Non degenerative amnsesic syndrome

Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Group Type EXPERIMENTAL

assessment of memory

Intervention Type BEHAVIORAL

circulating tPA dosage

Intervention Type BIOLOGICAL

ApoE4

Intervention Type GENETIC

Brain imaging examination MRI and PET examinations

Intervention Type OTHER

Frontotemporal lobe dementia

Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Group Type EXPERIMENTAL

assessment of memory

Intervention Type BEHAVIORAL

circulating tPA dosage

Intervention Type BIOLOGICAL

ApoE4

Intervention Type GENETIC

Brain imaging examination MRI and PET examinations

Intervention Type OTHER

Interventions

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assessment of memory

Intervention Type BEHAVIORAL

circulating tPA dosage

Intervention Type BIOLOGICAL

ApoE4

Intervention Type GENETIC

Brain imaging examination MRI and PET examinations

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Education level \> 7 years
* Native language: French
* Medical, neurological, neuropsychological and neuroradiological depth in accordance with the criteria for inclusion and exclusion-specific population, that is to say:

* Healthy young controls: between 18 and 40 years old; normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
* Healthy Middle-aged controls: between 40 and 60 years old; without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
* Healthy Elderly controls: over 60 years old, living at home, without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
* MCI patients: over 60 years old, presenting the current criteria for amnestic MCI including: i) memory complaint, ii) deficits of the episodic memory (lower performance of at least 1.5 SD from the norm for age and cultural level for one or more scores of episodic memory and iii) normal performances compared to the age and the educational level of all other cognitive functions as memory, including tests to assess cognitive abilities.
* Alzheimer's patients: presenting the standard criteria of NINCDS-ADRDA probable Alzheimer's disease, including abnormal global cognitive function and deficits in at least two cognitive domains identified by the diagnostic battery and a mild to moderate Alzheimer's disease (MMSE ≥ 15).

Exclusion Criteria

* The sudden onset of cognitive impairments (as opposed to their slow and gradual installation in Alzheimer's disease)
* A chronic neurological, psychiatric, endocrine, hepatic or infectious complaint
* A history of major disease (an uncontrolled diabetes, a lung, heart, metabolic, hematologic, endocrine disease or a severe cancer);
* A medication that may interfere with memory or metabolic measures
* A alcohol or drugs abuse
* claustrophobia, metallic object in the body
* A predominantly left-hand (score below 50% in Edinburgh Inventory).
* Protected adults, and persons not affiliated with a social security system will not participate in this study.
* The inclusion of a participant in another biomedical research protocol (during the study or within 12 months before inclusion)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent de La Sayette, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

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University Hospital Côte de Nacre

Caen, , France

Site Status

University Hospital Roger Salengro

Lille, , France

Site Status

University Hospital Pontchaillou

Rennes, , France

Site Status

University Hospital Rouen

Rouen, , France

Site Status

University Hospital Tours

Tours, , France

Site Status

Countries

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France

References

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Chetelat G. [Neuroimaging Alzheimer's disease: early diagnosis, monitoring, and mechanism understanding]. Med Sci (Paris). 2011 Feb;27(2):193-8. doi: 10.1051/medsci/2011272193. Epub 2011 Mar 8. French.

Reference Type BACKGROUND
PMID: 21382329 (View on PubMed)

Mevel K, Grassiot B, Chetelat G, Defer G, Desgranges B, Eustache F. [The default mode network: cognitive role and pathological disturbances]. Rev Neurol (Paris). 2010 Nov;166(11):859-72. doi: 10.1016/j.neurol.2010.01.008. Epub 2010 Mar 11. French.

Reference Type BACKGROUND
PMID: 20226489 (View on PubMed)

La Joie R, Fouquet M, Mezenge F, Landeau B, Villain N, Mevel K, Pelerin A, Eustache F, Desgranges B, Chetelat G. Differential effect of age on hippocampal subfields assessed using a new high-resolution 3T MR sequence. Neuroimage. 2010 Nov 1;53(2):506-14. doi: 10.1016/j.neuroimage.2010.06.024. Epub 2010 Jun 16.

Reference Type RESULT
PMID: 20600996 (View on PubMed)

Villain N, Landeau B, Groussard M, Mevel K, Fouquet M, Dayan J, Eustache F, Desgranges B, Chetelat G. A simple way to improve anatomical mapping of functional brain imaging. J Neuroimaging. 2010 Oct;20(4):324-33. doi: 10.1111/j.1552-6569.2010.00470.x.

Reference Type RESULT
PMID: 20331499 (View on PubMed)

Other Identifiers

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2007-A00414-49

Identifier Type: -

Identifier Source: org_study_id

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