Study of the Predictive Markers and the Pathophysiological Mechanisms of Alzheimer's Disease: Transverse and Longitudinal Approach in Anatomical and Functional Multimodal Imaging

Official Summary

Alzheimer's disease (AD) is a major public health problem due to its socio-economic weight. An early diagnosis of AD is urgently needed as it would constitute a determinant breakthrough from a social, financial and research standpoints. Therefore, the investigators need predictive markers of AD, and neuroimaging is a particularly promising tool, especially when using complementary neuroimaging techniques and a longitudinal design, allowing to assess the relationships between the different biomarkers of the disease, their dynamic and their chronology.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: FACTORIAL
• Masking: NONE
• Enrollment: 242 participants

Interventions

• BEHAVIORAL: Memory assessment — Neuropsycological tests including clinical and original tests to compare differences between each populations.
• BIOLOGICAL: Circulating biomarkers measure — ELISA tests from blood samples to compare differences between each populations.
• GENETIC: ApoE4 — Evaluation of apolipoprotein E polymorphism as a risk factor.
• OTHER: Brain imaging examination MRI and PET examinations — Structural and functional MRI FDG-PET to compare differences between each populations.

Primary Outcomes

• 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)

Eligibility Criteria

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 volunteers: between 18 and 40 years old; normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.65 SD).
  * Healthy Middle-aged volunteers: 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 (± 1.65 SD).
  * Healthy Elderly volunteers: 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 (± 1.65 SD).
  * SCI patients: over 60 years old ; memory complaints; memory complaint ; normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.65 SD).
  * MCI patients: presenting the current criteria for amnestic MCI including: i) memory complaint, ii) deficits of the episodic memory (lower performance of at least 1.65 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
* The cons-indications to MRI (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

Trial Locations

• GIP Cyceron, Caen, Calvados, France
• Inserm - EPHE - University of Caen U1077, Caen, France
• University Hospital Côte de Nacre, Caen, France
• University Hospital Roger Salengro, Lille, France
• University Hospital Pontchaillou, Rennes, France
• University Hospital Rouen, Rouen, France
• University Hospital Tours, Tours, France

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