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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Hospital, Caen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01530438
First received: February 22, 2010
Last updated: April 8, 2014
Last verified: March 2014
  Purpose

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 Intervention
Amyotrophic Lateral Sclerosis
Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Cognitive and Emotional Disorders in Amyotrophic Lateral Sclerosis : Neuropsychological, Imaging and Neuropathological Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • Cognitive, behavioural and emotional changes assesed with Neuropsychological tests. [ Time Frame: Between 9 and 12 mth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • brain imaging (anatomical MRI, functional MRI, PET using 18FDG) [ Time Frame: Between 9 and 12 mth ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: April 2009
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 ...

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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: NCT01530438

Locations
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
Principal Investigator: Laurence Carluer, MD University Hospital, Caen
  More Information

No publications provided

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01530438     History of Changes
Other Study ID Numbers: 08-067
Study First Received: February 22, 2010
Last Updated: April 8, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Caen:
Amyotrophic lateral sclerosis

Additional relevant MeSH terms:
Sclerosis
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014