Alzheimer Disease Clinical Trial
— INCASOfficial title:
Functionnal Magnetic Resonnance Imaging (fMRI)Study of Cerebral Substrates of New Musical and Pictorial Learning in Alzheimer Patients
NCT number | NCT01839422 |
Other study ID # | 2011-A00351-40 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | April 22, 2013 |
Last updated | April 8, 2014 |
Start date | January 2012 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
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) |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
France | GIP Cyceron | Caen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen | Institut National de la Santé Et de la Recherche Médicale, France, National Research Agency, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Succesful learning of new songs and paintings, succesful MRI acquisitions. | 10 days max. One week for the learning sessions, before MRI scans done one or two days after. | Yes |
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