Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
Cognitive and Emotional Disorders in Amyotrophic Lateral Sclerosis : Neuropsychological, Imaging and Neuropathological Study
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that involves not only motor structures, as was previously thought, but also brain areas dealing with cognition as well as parts of the limbic system. Clinical, imaging and pathological evidence suggests that ALS and fronto-temporal dementia (FTD) have several features in common, and that these two diseases could be the two ends of a pathological continuum.
Objectives : the investigators aim to study the clinical profile and magnitude of cognitive
disturbances, measure brain metabolism and assess cerebral atrophy in patients with ALS. The
relationships between cognitive, metabolic and anatomical data will be determined by the
correlation method. In addition, pathological studies will be carried out in deceased
patients having given their consent in advance, in order to quantify the neuronal loss and
UBIs.
Methods : the investigators plan to recruit 60 patients with ALS, 10 patients with ALS/FTD
(the diagnosis of dementia will rest on clinical data and formal neuropsychological testing)
and 20 normal control subjects. The ALS patients will be divided into 2 subsets on the basis
of a preliminary neuropsychological work-up, according to the presence or absence of
"subclinical cognitive impairment" as defined by abnormal scoring on tests not meeting the
criteria for dementia. In a second testing session carried out at the same time, a
comprehensive assessment of memory, behaviour and emotional changes will be done. All
subjects will then undergo morphological magnetic resonance imaging (MRI), resting-state
functional MRI and 18-fluorodeoxyglucose positron emission tomography (18FDG-PET). Whenever
possible, a second testing session will be carried out 9 to 12 months later in order to
quantify the cognitive deterioration, if any, and to find early predictors of the evolution
towards dementia. In deceased patients, the location and extent of neuronal loss will be
determined, as well as the location and number of UBIs.
Results and clinical relevance : this study is intended to improve our knowledge of the
clinical phenotype of ALS, and particularly to learn more about the extent of cognitive,
behavioural and emotional changes in this disease. This could in turn shed some further
light on the relationships between ALS and FTD.
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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