Amyotrophic Lateral SclerosisSLAMEMNCT01530438
Study of Cognitive and Emotional Disorders in Amyotrophic Lateral Sclerosis
A study testing MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Caen at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2009to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 :
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 1 recruiting
- Recruiting
University Hospital Center
Caen, 14033
Laurence - Carluer, hospital practitioner, 0231064624 ext. +33, carluer-l@chu-caen.fr
Fausto - Viader, Head of department, 0231064624 ext. +33, viader-f@chu-caen.fr
- Active, not recruiting
University Hospital Center
Rouen, 76031
About this study
Official title: Cognitive and Emotional Disorders in Amyotrophic Lateral Sclerosis : Neuropsychological, Imaging and Neuropathological Study
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.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research
- Keywords
- Amyotrophic lateral sclerosis
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the researchOther
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 group | Role | What they receive |
|---|---|---|
| ALS patients without cognitive disorders | Other | Amyotrophic lateral sclerosis without cognitive disorders Receives: Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research |
| ALS patients with cognitive disorders | Other | Amyotrophic lateral sclerosis with cognitive disorders Receives: Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research |
| ALS patients + frontal-temporal dementia | Other | Amyotrophic lateral sclerosis plus frontal-temporal dementia Receives: Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive, behavioural and emotional changes assesed with Neuropsychological tests.
Measured: Between 9 and 12 mth
Secondary outcomes (1)
brain imaging (anatomical MRI, functional MRI, PET using 18FDG)
Measured: Between 9 and 12 mth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startApr 2009
- Primary completionDec 2014 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence Carluer, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530438
- Sponsor's protocol ID
- 08-067
- Acronym
- SLAMEM
- Status last verified
- Mar 2014
- First submitted
- 22 Feb 2010
- Last updated
- 9 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Emotional Disorders in Amyotrophic Lateral Sclerosis : Neuropsychological, Imaging and Neuropathological Study
- ClinicalTrials.gov ID
- NCT01530438
- Acronym / sponsor ID
- SLAMEM / 08-067
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic lateral sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2014 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 10 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALS patients without cognitive disorders | Other | Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the researchAmyotrophic lateral sclerosis without cognitive disorders |
| ALS patients with cognitive disorders | Other | Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the researchAmyotrophic lateral sclerosis with cognitive disorders |
| ALS patients + frontal-temporal dementia | Other | Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the researchAmyotrophic lateral sclerosis plus frontal-temporal dementia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- All participants :
- Patients ALS :
- Patients ALS / FTD :
- Control Subjects :
Key exclusion criteria (14 listed)
- All particpants :
- 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
- Control Subjects :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the researchAt 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 ... | Other | ALS patients + frontal-temporal dementia, ALS patients with cognitive disorders, ALS patients without cognitive disorders |
Primary outcome
Cognitive, behavioural and emotional changes assesed with Neuropsychological tests.
Time frame: Between 9 and 12 mth
1 secondary outcome
brain imaging (anatomical MRI, functional MRI, PET using 18FDG)
Time frame: Between 9 and 12 mth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence Carluer, MD principal investigator
University Hospital, Caen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Caen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive, behavioural and emotional changes assesed with Neuropsychological tests. (time frame: Between 9 and 12 mth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2014.