Imaging of New Learning in Severe Alzheimer's Disease Patients (INCAS)
Primary Purpose
Alzheimer Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Memory assessment
Brain imaging examination MRI
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- 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 Elderly volunteers: 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.
- 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.
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
- The cons-indications to MRI (claustrophobia, metallic object in the body).
- A predominantly left-hand (score below 50% in Edinburgh Inventory)
Sites / Locations
- GIP CyceronRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Controls
Beginner Alzheimer's Disease patients
Severe Alzheimer's Disease patients
Arm Description
Memory assessment. Brain imaging examination MRI.
Memory assessment. Brain imaging examination MRI.
Memory assessment. Brain imaging examination MRI.
Outcomes
Primary Outcome Measures
Succesful learning of new songs and paintings, succesful MRI acquisitions.
Secondary Outcome Measures
Full Information
NCT ID
NCT01839422
First Posted
April 22, 2013
Last Updated
April 8, 2014
Sponsor
University Hospital, Caen
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, National Research Agency, France
1. Study Identification
Unique Protocol Identification Number
NCT01839422
Brief Title
Imaging of New Learning in Severe Alzheimer's Disease Patients
Acronym
INCAS
Official Title
Functionnal Magnetic Resonnance Imaging (fMRI)Study of Cerebral Substrates of New Musical and Pictorial Learning in Alzheimer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, National Research Agency, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This research attempts to better understand the altered and preserved memory mechanisms in Alzheimer disease, particularly to better apprehend learning implicit memory processes, and give a scientific support to non-pharmalogical interventions. At the present time, it is possible to delay the emergence of the symptoms related to this disease, eventually to decrease it, but not to cure it. Yet, care these patients became a crucial question and the solutions proposed to healthy aging people are not appropriate for Alzheimer patients who present specific disorders. The improvement of the quality of life of the institutionalized patients lies on a better comprehension of their disorders but also of their preserved abilities. The literature testifies of a great heterogeneity in the clinical expression of this disease, however we noticed two constants with regard to the capabilities generally announced as being preserved, on one hand, the implicit memory, and on the other hand the artistic aptitudes, and more particularly musical capabilities.
Patients with Alzheimer disease present a particularly severe and early deterioration of episodic memory. Thus, at the beginning of the disease the explicit acquisition of new knowledge becomes increasingly difficult. However, some clinical observations, such as new learning of unknown songs, even with patients at a severe stage of the illness, seem to support the assumption of a preservation of some implicit learning abilities. Indeed, several studies already showed preserved implicit memory capabilities among patients with Alzheimer disease, mostly at the beginning stage of the illness: preserved effects of perceptual priming, procedural learning. Thus, we are mainly interested by the effects of exposure and the rising of a feeling of familiarity, both showing preserved implicit learning abilities, for moderate to severe Alzheimer patients. However, no study was carried out to date using the neuroimaging techniques, among Alzheimer patients at a moderated to severe stage of illness, with the main objective to identify the cerebral substrates implied in the learning of new knowledge.
Indeed, several studies already showed preserved implicit memory capabilities among patients with Alzheimer disease, mostly were performed at the beginning stage of the illness and none of them have studied theses learning abilities for moderate to severe Alzheimer patients.
The objective of this work is to specify, in severe form of Alzheimer disease, the cognitive mechanisms allowing the memorizing (feeling of familiarity) of new information and thus to highlight neural networks underlying this learning process (recently learned stimuli vs old stimuli). The goal is to propose a positive image of the Alzheimer patients, in understanding which cognitive mechanisms and cerebral areas allow these learning capabilities.
20 patients Alzheimer at a moderate to severe stage, 20 patients at a mild to moderate stage of the illness, and 20 healthy aging participants, are selected after a neurological interview and a neuropsychological evaluation. The whole of the included participants take part of the experimental protocol organized in two phases: - the phase of familiarization and the phase of test. The phase of familiarization consists of the repeated exposure (daily session before the MRI acquisition) of new songs and new painting until obtaining a high feeling of familiarity for each item. The phase of test is carried out in the 3T MRI camera, it comprises an anatomical (T1, T2 MRI) and a functional acquisitions. The functional acquisition corresponds to a passive listening and seeing tasks of musical and pictorial stimuli. Finally, all participants realize a debriefing phase that allows obtaining a feedback on the familiarity of stimuli presented during the functional acquisition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Controls
Arm Type
Experimental
Arm Description
Memory assessment. Brain imaging examination MRI.
Arm Title
Beginner Alzheimer's Disease patients
Arm Type
Experimental
Arm Description
Memory assessment. Brain imaging examination MRI.
Arm Title
Severe Alzheimer's Disease patients
Arm Type
Experimental
Arm Description
Memory assessment. Brain imaging examination MRI.
Intervention Type
Behavioral
Intervention Name(s)
Memory assessment
Intervention Description
Cognitive assessment : Neuropsycological tests, learning sessions of new stimuli.
Intervention Type
Other
Intervention Name(s)
Brain imaging examination MRI
Intervention Description
Brain imaging examination : Structural and functional MRI to compare differences between each sample.
Primary Outcome Measure Information:
Title
Succesful learning of new songs and paintings, succesful MRI acquisitions.
Time Frame
10 days max. One week for the learning sessions, before MRI scans done one or two days after.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Elderly volunteers: 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.
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.
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
The cons-indications to MRI (claustrophobia, metallic object in the body).
A predominantly left-hand (score below 50% in Edinburgh Inventory)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien Chavant
Phone
+33231065495
Email
memoire-rechcerche.caen@inserm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent de La Sayette, MD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
GIP Cyceron
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent de La Sayette, MD
12. IPD Sharing Statement
Learn more about this trial
Imaging of New Learning in Severe Alzheimer's Disease Patients
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