Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 22, 2010
First Posted Date  ICMJE February 10, 2012
Last Update Posted Date April 9, 2014
Study Start Date  ICMJE April 2009
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
Cognitive, behavioural and emotional changes assesed with Neuropsychological tests. [ Time Frame: Between 9 and 12 mth ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
brain imaging (anatomical MRI, functional MRI, PET using 18FDG) [ Time Frame: Between 9 and 12 mth ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Cognitive and Emotional Disorders in Amyotrophic Lateral Sclerosis
Official Title  ICMJE Cognitive and Emotional Disorders in Amyotrophic Lateral Sclerosis : Neuropsychological, Imaging and Neuropathological Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE 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 ...
Study Arms  ICMJE
  • ALS patients without cognitive disorders
    Amyotrophic lateral sclerosis without cognitive disorders
    Intervention: Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research
  • ALS patients with cognitive disorders
    Amyotrophic lateral sclerosis with cognitive disorders
    Intervention: Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research
  • ALS patients + frontal-temporal dementia
    Amyotrophic lateral sclerosis plus frontal-temporal dementia
    Intervention: Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 9, 2012)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2015
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01530438
Other Study ID Numbers  ICMJE 08-067
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Caen
Study Sponsor  ICMJE University Hospital, Caen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Laurence Carluer, MD University Hospital, Caen
PRS Account University Hospital, Caen
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP