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

Arm | Intervention/treatment |
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ALS patients without cognitive disorders
Amyotrophic lateral sclerosis without cognitive disorders
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Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research
At T0 and T9 or 12 monts, are performed :
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ALS patients with cognitive disorders
Amyotrophic lateral sclerosis with cognitive disorders
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Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research
At T0 and T9 or 12 monts, are performed :
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ALS patients + frontal-temporal dementia
Amyotrophic lateral sclerosis plus frontal-temporal dementia
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Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research
At T0 and T9 or 12 monts, are performed :
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- Cognitive, behavioural and emotional changes assesed with Neuropsychological tests. [ Time Frame: Between 9 and 12 mth ]
- brain imaging (anatomical MRI, functional MRI, PET using 18FDG) [ Time Frame: Between 9 and 12 mth ]

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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 |
Inclusion Criteria:
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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
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Patients ALS :
- 18 to 80 years old
- Diagnostic defined or probable in according to the reviewed criteria of El Escorial.
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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.
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Control Subjects :
- 45 to 75 years old
- DRS ≥ 130
- BECK < 8
Exclusion Criteria:
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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.
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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)
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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

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
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 |
Principal Investigator: | Laurence Carluer, MD | University Hospital, Caen |
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 |
Amyotrophic lateral sclerosis |
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 |