Amyotrophic Lateral Sclerosis Clinical Trial
— MARIAOfficial title:
Microglial Activation Role In ALS (MARIA)
Verified date | May 2017 |
Source | University Hospital, Tours |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Neuroinflammation, characterized in particular by microglia activation, is an essential
component of Amyotrophic Lateral Sclerosis (ALS) pathogenesis. Translocator Protein (TSPO)
is recognized as a specific and sensitive biomarker of neuroinflammation, reflecting disease
activity. An experimental radiopharmaceutical specific of TSPO expression, namely
[18F]DPA714, allow to quantify this microglial activation using Positon Emission Tomography
(PET) imaging.
The purpose of this study is to longitudinally correlate the spatial distribution of
neuroinflammation with the pro- or anti-inflammatory state of activated microglia cells in
ALS, in order to evaluate neurotoxic or neuroprotective microglia activity, by complementary
approaches in 20 ALS patients:
- in vitro: measuring concentrations of several pro- and anti-inflammatory cytokines
secreted by microglial cells in the cerebrospinal fluid (CSF).
- in vivo: [18F]DPA714 PET imaging. These assays will be performed in the framework of
the clinical follow-up of ALS patients, at the diagnosis of ALS disease and 6 months
latter.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2017 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Signed informed consent - Age = 18 years old - Patient with probable or definite sporadic Amyotrophic Lateral Sclerosis (ALS) form according to the modified criteria of El Escorial - Treated with riluzole 2 weeks - Evolution less than 18 months - Mini-Mental State Examination (MMS) score = 26 and Frontal Assessment Battery (FAB) (normal) - Affiliated to a social security system Exclusion Criteria: - Another unbalanced progressive pathology - Vascular diseases (hypertension, diabetes, smoking, dyslipidemia) unbalanced - Forced vital capacity <75% - Weight loss> 10% of the weight before disease - Status "low affinity binder" or "mixed affinity binder", the TSPO respect to the [18 F] DPA-714, which can interfere with the process of neuroinflammation: drugs with anti-inflammatory drugs (NSAIDs, corticosteroids, azathioprine, anti-tumor necrosis factor (TNF), antibiotics) - Benzodiazepine in the week before the PET scan [18F] DPA-714 given the potential consequences for TSPO receivers - Contraindications to MRI in patients with: 1. Metallic foreign body eye. 2. Any implanted electronic medical irremovably (pacemaker, neurostimulator, cochlear implants ...) 3. Metal heart valve, 4. Vascular clips formerly located on cranial aneurysm. - Treatment in the month before the PET scan [18F] DPA-714 antagonist N-methyl-D-aspartate (NMDA) (memantine) - Pregnant women, lactating women, and women in age for procreation and without reliable contraception or without history of hysterectomy - ?Person under guardianship |
Country | Name | City | State |
---|---|---|---|
France | University Hospital | Tours |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Tours |
France,
Arlicot N, Vercouillie J, Ribeiro MJ, Tauber C, Venel Y, Baulieu JL, Maia S, Corcia P, Stabin MG, Reynolds A, Kassiou M, Guilloteau D. Initial evaluation in healthy humans of [18F]DPA-714, a potential PET biomarker for neuroinflammation. Nucl Med Biol. 20 — View Citation
Blasco H, Corcia P, Moreau C, Veau S, Fournier C, Vourc'h P, Emond P, Gordon P, Pradat PF, Praline J, Devos D, Nadal-Desbarats L, Andres CR. 1H-NMR-based metabolomic profiling of CSF in early amyotrophic lateral sclerosis. PLoS One. 2010 Oct 8;5(10):e1322 — View Citation
Corcia P, Ingre C, Blasco H, Press R, Praline J, Antar C, Veyrat-Durebex C, Guettard YO, Camu W, Andersen PM, Vourc'h P, Andres CR. Homozygous SMN2 deletion is a protective factor in the Swedish ALS population. Eur J Hum Genet. 2012 May;20(5):588-91. doi: — View Citation
Corcia P, Tauber C, Vercoullie J, Arlicot N, Prunier C, Praline J, Nicolas G, Venel Y, Hommet C, Baulieu JL, Cottier JP, Roussel C, Kassiou M, Guilloteau D, Ribeiro MJ. Molecular imaging of microglial activation in amyotrophic lateral sclerosis. PLoS One. — View Citation
Corcia P, Valdmanis P, Millecamps S, Lionnet C, Blasco H, Mouzat K, Daoud H, Belzil V, Morales R, Pageot N, Danel-Brunaud V, Vandenberghe N, Pradat PF, Couratier P, Salachas F, Lumbroso S, Rouleau GA, Meininger V, Camu W. Phenotype and genotype analysis i — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concentration of cytokines in cerebrospinal fluid (pg/mL) | 18 months | ||
Secondary | Fixation and distribution of [18F]DPA-714 (Binding Potential BP) | 18 months |
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