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| ID | Type | Description | Link |
|---|---|---|---|
| P080402 | Other Identifier | DRCD | |
| AOM 07225 | Other Identifier | DRCD |
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| Name | Class |
|---|---|
| Association Française contre les Myopathies (AFM), Paris | OTHER |
| ARS (Association pour la Recherche sur la Sclérose Latérale Amyotrophique) | UNKNOWN |
| Agence Générale des Equipements et Produits de Santé |
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The purpose of this study is to study the transporters of serotonin and dopamine in ALS patients in relation with the clinical phenotype, i.e., patients without stiffness, patients with pyramidal stiffness, patients with mixed (pyramidal and extra pyramidal) stiffness.
For such a goal the investigators will use SPECT to compare the binding of two specific tracers in ALS patients and in matched healthy controls.
Study design This study is a prospective cross-sectional controlled multicentric clinical study in 60 ALS patients and 20 controls.
Three cohorts of 20 ALS patients(patients without stiffness, patients with pyramidal stiffness, patients with mixed pyramidal and extra pyramidal stiffness) and 20 healthy controls will be included in this study
Study centres 40 ALS patients and 13 controls will be included in the Paris ALS center, 20 ALS patients and 7 controls will be included in the Tours ALS center.
MRI will be performed at the Neuroradiology department of salpetriere hospital (Paris) and Bretonneau hospital (Tours) SPECT will be done in the nuclear medicine center of each hospital (Paris- Tours).
Study duration Per patient or control, the study will be lasted one month. The total study duration will be two years
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients without stiffness | Other |
| |
| patients with pyramidal stiffness | Other |
| |
| patients with mixed stiffness | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM | Drug | 123 I-FP-CIT (DATSCAN) : 185 MBq (5 mCi), 2,5 ml will be injected via an arm intravenous catheter. 123I-ADAM:185 MBq,5 ml will be injected via an arm intravenous catheter. |
| Measure | Description | Time Frame |
|---|---|---|
| Dopamine transporter binding potential | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Serotonin transporter binding potential | 1 month | |
| Relationships between transporter binding potential and the clinical scores | 1 month |
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Inclusion Criteria:
Patients (men or women)
Patients will be assigned in three groups in relation with the clinical phenotypes:
Patients have to be capable of thoroughly understanding the information given; have signed the informed consent form (signature of spouse or family relative or acceptable third party is acceptable if the patient is physically unable to sign).
To have social insurance
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucette Lacomblez, MD | Pitié-Salpêtrière Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salpêtrière Hospital | Paris | 75013 | France | |||
| Bretonneau Hospital |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| C519528 | ioflupane |
| C413491 | 2-((2-((dimethylamino)methyl)phenyl)thio)-5-iodophenylamine |
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|
| Tours |
| 37044 |
| France |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |