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Amyotrophic Lateral Sclerosis | Study of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and Controls

Amyotrophic Lateral Sclerosis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: 1. 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 2. 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). 3. 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). 4. To have social insurance Exclusion Criteria: 1. Patients with a FRONTO temporal dementia (according to NEARY' criteria) 2. Patients with any concomitant life-threatening disease or any disease or impairment likely to interfere with functional assessment; 3. Patients with any major evolving psychiatric disorder or major anxiety disorder according to DSM-IV criteria (APA, 1996) 4. Patients receiving treatments which could interfere with the serotonin or dopamine metabolism 5. Patients with contraindications for the dat-scan and /or ADAM scan 6. Patients with contraindications for the MRI scan. 7. Patients with previous vascular, traumatic or tumoral cerebral lesions making impossible the quantification of the tracer 8. Patients with a cancer within the past 5 9. Patients child bearing, breast feeding or in the second part of their cycle without any efficient contraceptive device or treatment 10. 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;

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Amyotrophic Lateral Sclerosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM123 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

patients without stiffness

patients with pyramidal stiffness

patients with mixed stiffness

Study Status

Completed

Start Date: October 2012

Completed Date: October 2014

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Dopamine transporter binding potential

Secondary Outcome: Serotonin transporter binding potential

Study sponsors, principal investigator, and references

Principal Investigator: Lucette Lacomblez, MD

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Collaborator: Association Française contre les Myopathies (AFM), Paris

More information:https://clinicaltrials.gov/show/NCT01160263

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