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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01554202
First received: March 13, 2012
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

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.

Condition Intervention
Alzheimer's Disease
Behavioral: assessment of memory
Biological: circulating tPA dosage
Genetic: ApoE4
Other: Brain imaging examination MRI and PET examinations

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • Rate of volume change of whole brain, hippocampus and other structural MRI measures [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Rate of Decline as measured by: Cognitive Tests, Activities of Daily Living, and CDR Sum of Boxes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Rates of change on each specified biochemical biomarker [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Rates of change of glucose metabolism (FDG-PET) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Extent of amyloid deposition as measured by 18F-AV45 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Group differences for each imaging and biomarker measurement [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • APOE genotype [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 295
Study Start Date: January 2008
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Young controls
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
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.
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.
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.
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.
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.
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.
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.
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.
Behavioral: assessment of memory Biological: circulating tPA dosage Genetic: ApoE4 Other: Brain imaging examination MRI and PET examinations

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554202

Locations
France
University Hospital Côte de Nacre
Caen, France, 14033
University Hospital Roger Salengro
Lille, France, 59037
University Hospital Pontchaillou
Rennes, France, 35033
University Hospital Rouen
Rouen, France, 76031
University Hospital Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Caen
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Vincent de La Sayette, MD University Hospital, Caen
  More Information

Additional Information:
Publications:
Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01554202     History of Changes
Other Study ID Numbers: 2007-A00414-49
Study First Received: March 13, 2012
Last Updated: March 5, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Caen:
Alzheimer's disease
MCI
genetic
AV45-PET

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014