Multi-modal Neuroimaging in Alzheimer's Disease (IMAP)

Caen University Hospital

Status: Unknown

Conditions: Alzheimer's Disease

Treatments: Other: Brain imaging examination MRI and PET examinations; Biological: circulating tPA dosage; Genetic: ApoE4; Behavioral: assessment of memory

Study type: Interventional

Funder types: Other

Identifiers

NCT01554202

2007-A00414-49

Details and patient eligibility

About

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.

Enrollment: 295 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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295 participants in 9 patient groups

Young controls

Experimental group

Description:

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

Treatment:

Biological: circulating tPA dosage

Other: Brain imaging examination MRI and PET examinations

Genetic: ApoE4

Behavioral: assessment of memory

Middle age controls

Experimental group

Description:

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

Treatment:

Biological: circulating tPA dosage

Other: Brain imaging examination MRI and PET examinations

Genetic: ApoE4

Behavioral: assessment of memory

Elderly controls

Experimental group

Description:

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

Treatment:

Biological: circulating tPA dosage

Other: Brain imaging examination MRI and PET examinations

Genetic: ApoE4

Behavioral: assessment of memory

Autosomal dominant forms of early-onset Alzheimer disease

Experimental group

Description:

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

Treatment:

Biological: circulating tPA dosage

Other: Brain imaging examination MRI and PET examinations

Genetic: ApoE4

Behavioral: assessment of memory

Subjectif Cognitive Impariment patients

Experimental group

Description:

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

Treatment:

Biological: circulating tPA dosage

Other: Brain imaging examination MRI and PET examinations

Genetic: ApoE4

Behavioral: assessment of memory

Mild Cognitive Impairment patients

Experimental group

Description:

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

Treatment:

Biological: circulating tPA dosage

Other: Brain imaging examination MRI and PET examinations

Genetic: ApoE4

Behavioral: assessment of memory

Alzheimer Disease patients

Experimental group

Description:

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

Treatment:

Biological: circulating tPA dosage

Other: Brain imaging examination MRI and PET examinations

Genetic: ApoE4

Behavioral: assessment of memory

Non degenerative amnsesic syndrome

Experimental group

Description:

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

Treatment:

Biological: circulating tPA dosage

Other: Brain imaging examination MRI and PET examinations

Genetic: ApoE4

Behavioral: assessment of memory

Frontotemporal lobe dementia

Experimental group

Description:

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

Treatment:

Biological: circulating tPA dosage

Other: Brain imaging examination MRI and PET examinations

Genetic: ApoE4

Behavioral: assessment of memory