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Multi-modal Neuroimaging in Alzheimer's Disease

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01554202
Acronym
IMAP
Enrollment
295
Registered
2012-03-14
Start date
2008-01-31
Completion date
Unknown
Last updated
2013-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease, MCI, genetic, AV45-PET

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.

Interventions

BEHAVIORALassessment of memory
BIOLOGICALcirculating tPA dosage
GENETICApoE4

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frame
Rate of volume change of whole brain, hippocampus and other structural MRI measures3 years
Rate of Decline as measured by: Cognitive Tests, Activities of Daily Living, and CDR Sum of Boxes3 years
Rates of change on each specified biochemical biomarker3 years
Rates of change of glucose metabolism (FDG-PET)3 years
Extent of amyloid deposition as measured by 18F-AV453 years
Group differences for each imaging and biomarker measurement3 years
APOE genotype3 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026