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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 13, 2012
First Posted Date  ICMJE March 14, 2012
Last Update Posted Date March 6, 2013
Study Start Date  ICMJE January 2008
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
  • 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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT01554202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multi-modal Neuroimaging in Alzheimer's Disease
Official Title  ICMJE Study of the Predictive Markers and the Pathophysiological Mechanisms of Alzheimer's Disease: Transverse and Longitudinal Approach in Anatomical and Functional Multimodal Imaging
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Behavioral: assessment of memory
  • Biological: circulating tPA dosage
  • Genetic: ApoE4
  • Other: Brain imaging examination MRI and PET examinations
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 13, 2012)
295
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01554202
Other Study ID Numbers  ICMJE 2007-A00414-49
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Caen
Study Sponsor  ICMJE University Hospital, Caen
Collaborators  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Investigators  ICMJE
Principal Investigator: Vincent de La Sayette, MD University Hospital, Caen
PRS Account University Hospital, Caen
Verification Date March 2013

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