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Study of Cognitive and Emotional Disorders in Amyotrophic Lateral Sclerosis (SLAMEM)

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ClinicalTrials.gov Identifier: NCT01530438
Recruitment Status : Unknown
Verified March 2014 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : February 10, 2012
Last Update Posted : April 9, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Cognitive and Emotional Disorders in Amyotrophic Lateral Sclerosis : Neuropsychological, Imaging and Neuropathological Study
Study Start Date : April 2009
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : May 2015

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Arms and Interventions
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Arm Intervention/treatment
ALS patients without cognitive disorders
Amyotrophic lateral sclerosis without cognitive disorders
 Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research

At T0 and T9 or 12 monts, are performed :

  • Imaging : fMRI at rest and anatomical MRI
  • Neuropsychological assessments : general cognitive functioning, theory of mind, executive functions ...
ALS patients with cognitive disorders
Amyotrophic lateral sclerosis with cognitive disorders
 Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research

At T0 and T9 or 12 monts, are performed :

  • Imaging : fMRI at rest and anatomical MRI
  • Neuropsychological assessments : general cognitive functioning, theory of mind, executive functions ...
ALS patients + frontal-temporal dementia
Amyotrophic lateral sclerosis plus frontal-temporal dementia
 Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research

At T0 and T9 or 12 monts, are performed :

  • Imaging : fMRI at rest and anatomical MRI
  • Neuropsychological assessments : general cognitive functioning, theory of mind, executive functions ...


Outcome Measures
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Primary Outcome Measures :
  1. Cognitive, behavioural and emotional changes assesed with Neuropsychological tests. [ Time Frame: Between 9 and 12 mth ]

Secondary Outcome Measures :
  1. brain imaging (anatomical MRI, functional MRI, PET using 18FDG) [ Time Frame: Between 9 and 12 mth ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All participants :

    • study level > 7 years
    • mother tongue : french
    • signature of the informed consent of the protocol in accord with the Comité de Protection des Personnes
    • medical, neurological, neuroradiological and neuropsychological approfondis in accord with the specific inclusion and non inclusion criteria spécifiques at each population

  • Patients ALS :

    • 18 to 80 years old
    • Diagnostic defined or probable in according to the reviewed criteria of El Escorial.

  • Patients ALS / FTD :

    • 18 to 8O years old
    • Diagnostic defined or probable in according to El Escorial reviewed criteria and diagnostic of frontal-temporal dementia in according to Lund et Manchester criteria.

  • Control Subjects :

    • 45 to 75 years old
    • DRS ≥ 130
    • BECK < 8

Exclusion Criteria:

  • All particpants :

    • Major past history (chronic pulmonary disease, cardiac disease, metabolic, haematological, endocrinological or severe immunological, cancer) ;
    • Chronic use of alcohol or drugs ;
    • IRM contraindications

Protected adults, and persons non affiliated to social protection system won't be able to participate at this study. The inclusion of the participant in another biomedical research protocol(during the study or into 12 months before the inclusion) is too a non inclusion criterion.

  • Patients SLA and patients SLA / FTD

    • Severe bulbar disorders
    • Severe restrictive respiratory insufficiency (VC<50%) with orthopny
    • Communication disorders with motor origin (non assessable tests)

  • Control Subjects :

    • Pregnant or nursing women
    • Unability to submit at the study medical follow-up for geographic or psychiatric reasons(previous or ongoing).
    • DRS score < 130
    • Depressive syndrome (BECK) ≥ 8
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530438


Locations
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France
University Hospital Center Recruiting
Caen, France, 14033
Contact: Laurence - Carluer, hospital practitioner    0231064624 ext +33    carluer-l@chu-caen.fr   
Contact: Fausto - Viader, Head of department    0231064624 ext +33    viader-f@chu-caen.fr   
Principal Investigator: Laurence - Carluer, Hospital Practitioner         
University Hospital Center Active, not recruiting
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Caen
Investigators
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Principal Investigator: Laurence Carluer, MD University Hospital, Caen
More Information
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01530438    
Other Study ID Numbers: 08-067
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: March 2014
Keywords provided by University Hospital, Caen:
Amyotrophic lateral sclerosis
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
 Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action