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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborators:
Association Française contre les Myopathies (AFM), Paris
ARS (Association pour la Recherche sur la Sclérose Latérale Amyotrophique)
AGEPS
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01160263
First received: July 9, 2010
Last updated: June 13, 2014
Last verified: June 2014
  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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Dopamine transporter binding potential [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 2014
Estimated Primary Completion Date: October 2014 (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
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160263

Contacts
Contact: Lucette LACOMBLEZ, MD +33 1 42 16 24 72 lucette.lacomblez@psl.aphp.fr

Locations
France
Salpêtrière Hospital Recruiting
Paris, France, 75013
Contact: Lucette Lacomblez         
Principal Investigator: Lucette Lacomblez, MD         
Bretonneau Hospital Recruiting
Tours, France, 37044
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Association Française contre les Myopathies (AFM), Paris
ARS (Association pour la Recherche sur la Sclérose Latérale Amyotrophique)
AGEPS
Investigators
Principal Investigator: Lucette Lacomblez, MD Hôpital de la Salpétrière
  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: June 13, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
ALS
serotonin
dopamine

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
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 October 16, 2014