Clinical trial: Study of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and Controls (NCT01160263)

Eligibility criteria:
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;
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 39 Years old.
Subject must be at most 66 Years

Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? 1