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

Amyotrophic Lateral Sclerosis Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial 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 ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01160263
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase Phase 3
Start date October 2012
Completion date October 2014
View Details
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