Overview

This trial is active, not recruiting.

Condition alzheimer's disease
Treatments assessment of memory, circulating tpa dosage, apoe4, brain imaging examination mri and pet examinations
Sponsor University Hospital, Caen
Collaborator Institut National de la Santé Et de la Recherche Médicale, France
Start date January 2008
End date December 2021
Trial size 295 participants
Trial identifier NCT01554202, 2007-A00414-49

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
assessment of memory
circulating tpa dosage
apoe4
brain imaging examination mri and pet examinations
(Experimental)
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
assessment of memory
circulating tpa dosage
apoe4
brain imaging examination mri and pet examinations
(Experimental)
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
assessment of memory
circulating tpa dosage
apoe4
brain imaging examination mri and pet examinations
(Experimental)
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
assessment of memory
circulating tpa dosage
apoe4
brain imaging examination mri and pet examinations
(Experimental)
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
assessment of memory
circulating tpa dosage
apoe4
brain imaging examination mri and pet examinations
(Experimental)
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
assessment of memory
circulating tpa dosage
apoe4
brain imaging examination mri and pet examinations
(Experimental)
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
assessment of memory
circulating tpa dosage
apoe4
brain imaging examination mri and pet examinations
(Experimental)
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
assessment of memory
circulating tpa dosage
apoe4
brain imaging examination mri and pet examinations
(Experimental)
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
assessment of memory
circulating tpa dosage
apoe4
brain imaging examination mri and pet examinations

Primary Outcomes

Measure
Rate of volume change of whole brain, hippocampus and other structural MRI measures
time frame: 3 years
Rate of Decline as measured by: Cognitive Tests, Activities of Daily Living, and CDR Sum of Boxes
time frame: 3 years
Rates of change on each specified biochemical biomarker
time frame: 3 years
Rates of change of glucose metabolism (FDG-PET)
time frame: 3 years
Extent of amyloid deposition as measured by 18F-AV45
time frame: 3 years
Group differences for each imaging and biomarker measurement
time frame: 3 years
APOE genotype
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

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
Principal investigator Vincent de La Sayette, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by University Hospital, Caen.