Multi-modal Neuroimaging in Alzheimer's Disease
IMAP
Study of the Predictive Markers and the Pathophysiological Mechanisms of Alzheimer's Disease: Transverse and Longitudinal Approach in Anatomical and Functional Multimodal Imaging
1 other identifier
interventional
295
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 13, 2012
CompletedFirst Posted
Study publicly available on registry
March 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedMarch 6, 2013
March 1, 2013
13.9 years
March 13, 2012
March 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Rate of volume change of whole brain, hippocampus and other structural MRI measures
3 years
Rate of Decline as measured by: Cognitive Tests, Activities of Daily Living, and CDR Sum of Boxes
3 years
Rates of change on each specified biochemical biomarker
3 years
Rates of change of glucose metabolism (FDG-PET)
3 years
Extent of amyloid deposition as measured by 18F-AV45
3 years
Group differences for each imaging and biomarker measurement
3 years
APOE genotype
3 years
Study Arms (9)
Young controls
EXPERIMENTALAssessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Middle age controls
EXPERIMENTALAssessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Elderly controls
EXPERIMENTALAssessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Autosomal dominant forms of early-onset Alzheimer disease
EXPERIMENTALAssessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Subjectif Cognitive Impariment patients
EXPERIMENTALAssessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Mild Cognitive Impairment patients
EXPERIMENTALAssessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Alzheimer Disease patients
EXPERIMENTALAssessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Non degenerative amnsesic syndrome
EXPERIMENTALAssessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Frontotemporal lobe dementia
EXPERIMENTALAssessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
Interventions
Eligibility Criteria
You may qualify if:
- Education level \> 7 years
- Native language: French
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University Hospital Côte de Nacre
Caen, 14033, France
University Hospital Roger Salengro
Lille, 59037, France
University Hospital Pontchaillou
Rennes, 35033, France
University Hospital Rouen
Rouen, 76031, France
University Hospital Tours
Tours, 37044, France
Related Publications (4)
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.
PMID: 21382329BACKGROUNDMevel 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.
PMID: 20226489BACKGROUNDLa 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.
PMID: 20600996RESULTVillain 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.
PMID: 20331499RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent de La Sayette, MD
University Hospital, Caen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2012
First Posted
March 14, 2012
Study Start
January 1, 2008
Primary Completion
December 1, 2021
Last Updated
March 6, 2013
Record last verified: 2013-03