- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01530438
Study of Cognitive and Emotional Disorders in Amyotrophic Lateral Sclerosis (SLAMEM)
Cognitive and Emotional Disorders in Amyotrophic Lateral Sclerosis : Neuropsychological, Imaging and Neuropathological Study
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
-
Caen, France, 14033
- Recruiting
- University Hospital Center
-
Contact:
- Laurence - Carluer, hospital practitioner
- Phone Number: +33 0231064624
- Email: carluer-l@chu-caen.fr
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Contact:
- Fausto - Viader, Head of department
- Phone Number: +33 0231064624
- Email: viader-f@chu-caen.fr
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Principal Investigator:
- Laurence - Carluer, Hospital Practitioner
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Rouen, France, 76031
- Active, not recruiting
- University Hospital Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: ALS patients without cognitive disorders
Amyotrophic lateral sclerosis without cognitive disorders
|
At T0 and T9 or 12 monts, are performed :
|
OTHER: ALS patients with cognitive disorders
Amyotrophic lateral sclerosis with cognitive disorders
|
At T0 and T9 or 12 monts, are performed :
|
OTHER: ALS patients + frontal-temporal dementia
Amyotrophic lateral sclerosis plus frontal-temporal dementia
|
At T0 and T9 or 12 monts, are performed :
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cognitive, behavioural and emotional changes assesed with Neuropsychological tests.
Time Frame: Between 9 and 12 mth
|
Between 9 and 12 mth
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
brain imaging (anatomical MRI, functional MRI, PET using 18FDG)
Time Frame: Between 9 and 12 mth
|
Between 9 and 12 mth
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laurence Carluer, MD, University Hospital, Caen
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Spinal Cord Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Sclerosis
- Motor Neuron Disease
- Amyotrophic Lateral Sclerosis
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Fluorodeoxyglucose F18
Other Study ID Numbers
- 08-067
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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