Multi-modal Neuroimaging in Alzheimer's Disease (IMAP)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Alzheimer's Disease |
Behavioral: assessment of memory Biological: circulating tPA dosage Genetic: ApoE4 Other: Brain imaging examination MRI and PET examinations |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Study of the Predictive Markers and the Pathophysiological Mechanisms of Alzheimer's Disease: Transverse and Longitudinal Approach in Anatomical and Functional Multimodal Imaging |
- Rate of volume change of whole brain, hippocampus and other structural MRI measures [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Rate of Decline as measured by: Cognitive Tests, Activities of Daily Living, and CDR Sum of Boxes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Rates of change on each specified biochemical biomarker [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Rates of change of glucose metabolism (FDG-PET) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Extent of amyloid deposition as measured by 18F-AV45 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Group differences for each imaging and biomarker measurement [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- APOE genotype [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 295 |
| Study Start Date: | January 2008 |
| Estimated Primary Completion Date: | December 2021 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Young controls
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
|
Behavioral: assessment of memory Biological: circulating tPA dosage Genetic: ApoE4 Other: Brain imaging examination MRI and PET examinations |
|
Experimental: Middle age controls
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
|
Behavioral: assessment of memory Biological: circulating tPA dosage Genetic: ApoE4 Other: Brain imaging examination MRI and PET examinations |
|
Experimental: Elderly controls
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
|
Behavioral: assessment of memory Biological: circulating tPA dosage Genetic: ApoE4 Other: Brain imaging examination MRI and PET examinations |
|
Experimental: Autosomal dominant forms of early-onset Alzheimer disease
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
|
Behavioral: assessment of memory Biological: circulating tPA dosage Genetic: ApoE4 Other: Brain imaging examination MRI and PET examinations |
|
Experimental: Subjectif Cognitive Impariment patients
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
|
Behavioral: assessment of memory Biological: circulating tPA dosage Genetic: ApoE4 Other: Brain imaging examination MRI and PET examinations |
|
Experimental: Mild Cognitive Impairment patients
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
|
Behavioral: assessment of memory Biological: circulating tPA dosage Genetic: ApoE4 Other: Brain imaging examination MRI and PET examinations |
|
Experimental: Alzheimer Disease patients
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
|
Behavioral: assessment of memory Biological: circulating tPA dosage Genetic: ApoE4 Other: Brain imaging examination MRI and PET examinations |
|
Experimental: Non degenerative amnsesic syndrome
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
|
Behavioral: assessment of memory Biological: circulating tPA dosage Genetic: ApoE4 Other: Brain imaging examination MRI and PET examinations |
|
Experimental: Frontotemporal lobe dementia
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
|
Behavioral: assessment of memory Biological: circulating tPA dosage Genetic: ApoE4 Other: Brain imaging examination MRI and PET examinations |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations| France | |
| University Hospital Côte de Nacre | |
| Caen, France, 14033 | |
| University Hospital Roger Salengro | |
| Lille, France, 59037 | |
| University Hospital Pontchaillou | |
| Rennes, France, 35033 | |
| University Hospital Rouen | |
| Rouen, France, 76031 | |
| University Hospital Tours | |
| Tours, France, 37044 | |
| Principal Investigator: | Vincent de La Sayette, MD | University Hospital, Caen |
More Information
Additional Information:
Publications:
| Responsible Party: | University Hospital, Caen |
| ClinicalTrials.gov Identifier: | NCT01554202 History of Changes |
| Other Study ID Numbers: | 2007-A00414-49 |
| Study First Received: | March 13, 2012 |
| Last Updated: | March 5, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Caen:
|
Alzheimer's disease MCI genetic AV45-PET |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013