Study of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and Controls (DOSERAL)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Amyotrophic Lateral Sclerosis |
Drug: SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Study of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and Controls. Analysis With 123I-FP-CIT (Datscan) and 123I-ADAM Brain SPECT |
- Dopamine transporter binding potential [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Serotonin transporter binding potential [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Relationships between transporter binding potential and the clinical scores [ Time Frame: 1 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| patients without stiffness |
Drug: SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
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. Other Name: PECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
|
| patients with pyramidal stiffness |
Drug: SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
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. Other Name: PECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
|
| patients with mixed stiffness |
Drug: SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
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. Other Name: PECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
|
Detailed Description:
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
Eligibility| Ages Eligible for Study: | 39 Years to 66 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Patients (men or women)
- between 39 (exclusive) and 66 (inclusive) years old
- with a sporadic ALS, defined, probable or laboratory possible
- with a disease duration between 3 months (inclusive) and 5 years (exclusive)
- treated with rilutek at 100 mg/ day since at least 1 month
Patients will be assigned in three groups in relation with the clinical phenotypes:
- 20 patients without stiffness
- 20 patients with pyramidal stiffness (spasticity patients).
- 20 patients with mixed stiffness (both spasticity and rigidity).
- 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:
- Patients with a FRONTO temporal dementia (according to NEARY' criteria)
- Patients with any concomitant life-threatening disease or any disease or impairment likely to interfere with functional assessment;
- Patients with any major evolving psychiatric disorder or major anxiety disorder according to DSM-IV criteria (APA, 1996)
- Patients receiving treatments which could interfere with the serotonin or dopamine metabolism
- Patients with contraindications for the dat-scan and /or ADAM scan
- Patients with contraindications for the MRI scan.
- Patients with previous vascular, traumatic or tumoral cerebral lesions making impossible the quantification of the tracer
- Patients with a cancer within the past 5
- Patients child bearing, breast feeding or in the second part of their cycle without any efficient contraceptive device or treatment
- Patients liable not to be co-operative or comply with the trial requirements (as assessed by the investigator), or unable to be reached in the event of an emergency;
Contacts and Locations| Contact: Lucette LACOMBLEZ, MD | +33 1 42 16 24 72 | lucette.lacomblez@psl.aphp.fr |
| France | |
| Salpêtrière Hospital | Recruiting |
| Paris, France, 75013 | |
| Contact: Lucette Lacomblez | |
| Principal Investigator: Lucette Lacomblez, MD | |
| Bretonneau Hospital | Recruiting |
| Tours, France, 37044 | |
| Principal Investigator: | Lucette Lacomblez, MD | Pitié Salpêtrière Hospital |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01160263 History of Changes |
| Other Study ID Numbers: | P080402, P080402, AOM 07225 |
| Study First Received: | July 9, 2010 |
| Last Updated: | October 30, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
ALS serotonin dopamine |
Additional relevant MeSH terms:
|
Amyotrophic Lateral Sclerosis Sclerosis Motor Neuron Disease Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases TDP-43 Proteinopathies Neuromuscular Diseases Proteostasis Deficiencies Metabolic Diseases Pathologic Processes Dopamine Dopamine Agents |
Serotonin Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents Serotonin Receptor Agonists Serotonin Agents |
ClinicalTrials.gov processed this record on May 22, 2013