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

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ClinicalTrials.gov Identifier: NCT01554202
Recruitment Status : Active, not recruiting
First Posted : March 14, 2012
Last Update Posted : March 6, 2013
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Caen

March 13, 2012
March 14, 2012
March 6, 2013
January 2008
December 2021   (Final data collection date for primary outcome 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 ]
Not Provided
Complete list of historical versions of study NCT01554202 on ClinicalTrials.gov Archive Site
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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

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.
Not Provided
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Alzheimer's Disease
  • Behavioral: assessment of memory
  • Biological: circulating tPA dosage
  • Genetic: ApoE4
  • Other: Brain imaging examination MRI and PET examinations
  • Experimental: Young controls
    Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • Behavioral: assessment of memory
    • Biological: circulating tPA dosage
    • Genetic: ApoE4
    • Other: Brain imaging examination MRI and PET examinations

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
295
Same as current
Not Provided
December 2021   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01554202
2007-A00414-49
Yes
Not Provided
Not Provided
University Hospital, Caen
University Hospital, Caen
Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Vincent de La Sayette, MD University Hospital, Caen
University Hospital, Caen
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP